U.S. Customs and Border Protection · CROSS Database · 2 HTS codes referenced
Primary HTS Code
9019.20.00
$361.5M monthly imports
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Ruling Age
11 years
1 related ruling
Data compiled from CBP CROSS Rulings, Census Bureau Trade Data · As of 2026-04-28 · Updates monthly
Application for Further Review of Protest No. 0411-11-100018; Medisize Blue Small Heat & Moisture Exchanger/Filter and Medisize Gold Heater
HQ H202337 August 21, 2014 CLA-2 RR:CTF:TCM H202337 EGJ CATEGORY: CLASSIFICATION TARIFF NO.: 9019.20.00; 8516.10.00 Port Director Port of Hartford U.S. Customs and Border Protection Bradley International Airport International Arrivals Building Windsor Locks, CT 06096 Attn: John W. Cox, Import Specialist RE: Application for Further Review of Protest No. 0411-11-100018; Medisize Blue Small Heat & Moisture Exchanger/Filter and Medisize Gold Heater Dear Port Director: This is in response to Protest No. 0411-11-100018, dated November 7, 2011, filed on behalf of Medisize U.S., Inc. (Medisize) in response to your classification of the Medisize Blue Small Heat and Moisture Exchanger/Filter (HMEF) and the Medisize Gold Heater (the heater) under the Harmonized Tariff Schedule of the United States (HTSUS). FACTS: A medical ventilator is a machine designed to mechanically move air in and out of the lungs of a patient who cannot breathe independently. The breathing circuit is the system of tubes and apparatus which attach to the medical ventilator. The subject merchandise consists of two different devices designed for use with a medical ventilator and breathing circuit. The first device is the HMEF - a plastic cylinder fitted with a cellulose membrane and a textile filter. The HMEF is designed to be inserted into the patient’s breathing circuit. The cellulose membrane acts as a passive, warm air humidifier; it catches warm air and moisture exhaled by the patient and returns it to the patient during inhalations. According to the CBP Laboratory Report, the cellulose membrane is a roll consisting of two layers wound together measuring approximately 15 mm in width and 50 mm in diameter. It weighs approximately 8.5 grams and has been placed in the patient half of the plastic housing. The membrane is composed of natural paper and wood pulp fibers. According to the literature submitted with the AFR request, the materials selected for the membrane achieve the highest levels of humidification available on the market. The textile filter sanitizes the exchanged air by trapping airborne particles through both electrostatic and physical filtration. The HMEF replaces the function of a patient’s upper respiratory tract by reducing the risk of post-operative hypothermia or bacterial/viral infections during breathing. A picture of the HMEF is provided below: The second device is the heater, which is part of the Medisize Gold breathing circuit. Both the heater and a water tube attach to a heat and moisture exchanger (HME), which is identical to the above HMEF except that it lacks the textile filter. The heater has a heater plate which gets hot as electric current runs through it. The heater plate warms up the water delivered through the water tube. A special membrane in the HME allows only warm water vapor to pass through the breathing circuit. A picture of the Medisize Gold breathing circuit is provided below (the diagram labels the heater as the Positive Temperature control element): On January 5, 2011, and January 19, 2011, Medisize made two entries of the subject merchandise. Medisize classified both the HMEF and the heater under subheading 9019.20.00, HTSUS, as accessories to respiration apparatus. On October 21, 2011, U.S. Customs and Border Protection (CBP) liquidated the entries of HMEFs under subheading 5911.90.00, HTSUS, as textile articles for technical uses, and the entries of heaters under subheading 8419.89.95, HTSUS, as material heaters. On November 7, 2011, Medisize timely submitted the subject Protest and Application for Further Review (AFR). The matter is protestable as a decision on classification. 19 U.S.C. §1514(a)(2). Medisize’s AFR satisfies the application criteria because Medisize alleges questions of law and fact which have not yet been ruled upon by CBP. 19 C.F.R. § 174.24(b). Namely, Medisize alleges that the HMEF cannot be classified as a textile article because it also consists of a cellulose membrane. Further, Medisize asserts that the relevant Explanatory Notes exclude the heater from classification in heading 8419, HTSUS. ISSUE: 1. What is the tariff classification of the Medisize Small Blue Heat & Moisture Exchanger/Filter (HMEF)? 2. What is the tariff classification of the Medisize Gold Heater? LAW AND ANALYSIS: Merchandise imported into the United States is classified under the HTSUS. Tariff classification is governed by the principles set forth in the General Rules of Interpretation (GRIs) and, in the absence of special language or context, which requires otherwise, by the Additional U.S. Rules of Interpretation. The GRIs and the Additional U.S. Rules of Interpretation are part of the HTSUS and are to be considered statutory provisions of law for all purposes. GRI 1 requires that classification be determined first according to the terms of the headings of the tariff schedule and any relative section or chapter notes and, unless otherwise required, according to the remaining GRIs taken in their appropriate order. Under GRI 6, the classification of goods in the subheadings of a heading shall be determined according to the terms of those subheadings and any related subheading notes and, mutatis mutandis, to GRIs 1 through 5. The HTSUS provisions at issue provide, in pertinent part, as follows: 4823 Other paper, paperboard, cellulose wadding and webs of cellulose fibers, cut to size or shape; other articles of paper pulp, paper, paperboard, cellulose wadding or webs of cellulose fibers: * * * 5911 Textile products and articles, for technical uses, specified in note 7 to this chapter: 5911 Other … * * * 8419 Machinery, plant or laboratory equipment, whether or not electrically heated (excluding furnaces, ovens and other equipment of heading 8514), for the treatment of materials by a process involving a change of temperature such as heating, cooking, roasting, distilling, rectifying, sterilizing, pasteurizing, steaming, drying, evaporating, vaporizing, condensing or cooling, other than machinery or plant of a kind used for domestic purposes; instantaneous or storage water heaters, nonelectric; parts thereof: Other machinery, plant or equipment: 8419.89 Other * * * 8516 Electric instantaneous or storage water heaters and immersion heaters …: 8516.10.00 Electric instantaneous or storage water heaters and immersion heaters … * * * 9019 [O]zone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof: 9019.20.00 Ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; parts and accessories thereof … * * * Legal Note 1(a) to Chapter 90 states as follows: 1. This chapter does not cover: (a) Articles of a kind used in machines, appliances or for other technical uses, of vulcanized rubber other than hard rubber (heading 4016), of leather or of composition leather (heading 4205) or of textile material (heading 5911) * * * Legal Note 2 to Chapter 90 states as follows: 2. Subject to note 1 above, parts and accessories for machines, apparatus, instruments or articles of this chapter are to be classified according to the following rules: (a) Parts and accessories which are goods included in any of the headings of this chapter or of chapter 84, 85 or 91 (other than heading 8487, 8548 or 9033) are in all cases to be classified in their respective headings; (b) Other parts and accessories, if suitable for use solely or principally with a particular kind of machine, instrument or apparatus, or with a number of machines, instruments or apparatus of the same heading (including a machine, instrument or apparatus of heading 9010, 9013 or 9031) are to be classified with the machines, instruments or apparatus of that kind; (c) All other parts and accessories are to be classified in heading 9033. * * * GRI 3 provides as follows: 3. When, by application of rule 2(b) or for any other reason, goods are, prima facie, classifiable under two or more headings, classification shall be effected as follows: (a) The heading which provides the most specific description shall be preferred to headings providing a more general description. However, when two or more headings each refer to part only of the materials or substances contained in mixed or composite goods or to part only of the items in a set put up for retail sale, those headings are to be regarded as equally specific in relation to those goods, even if one of them gives a more complete or precise description of the goods. (b) Mixtures, composite goods consisting of different materials or made up of different components, and goods put up in sets for retail sale, which cannot be classified by reference to 3(a), shall be classified as if they consisted of the material or component which gives them their essential character, insofar as this criterion is applicable. (c) When goods cannot be classified by reference to 3(a) or 3(b), they shall be classified under the heading which occurs last in numerical order among those which equally merit consideration. * * * The Harmonized Commodity Description and Coding System Explanatory Notes (“ENs”) constitute the official interpretation of the Harmonized System. While not legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the Harmonized System at the international level and are generally indicative of the proper interpretation of these headings. See T.D. 89-80, 54 Fed. Reg. 35127, 35128 (August 23, 1989). EN 59.11 provides, in pertinent part, as follows: (B) TEXTILE ARTICLES OF A KIND USED FOR TECHNICAL PURPOSES All textile articles of a kind used for technical purposes (other than those of headings 59.08 to 59.10) are classified in this heading and not elsewhere in Section XI (see Note 7 (b) to the Chapter); for example: (1) Any of the fabrics of (A) above which have been made up (cut to shape, assembled by sewing, etc.), for example, straining cloths for oil presses made by assembly of several pieces of fabric; bolting cloth cut to shape and trimmed with tapes or furnished with metal eyelets or cloth mounted on a frame for use in screen printing … The textile articles of this heading may incorporate accessories in other material provided the articles remain essentially articles of textile. EN 84.19 provides, in pertinent part, as follows: With these exceptions, the heading covers machinery and plant designed to submit materials (solid, liquid or gaseous) to a heating or cooling process in order to cause a simple change of temperature, or to cause a transformation of the materials resulting principally from the temperature change (e.g., heating, cooking, roasting, distilling, rectifying, sterilising, pasteurising, steaming, drying, evaporating, vaporising, condensing or cooling processes). But the heading excludes machinery and plant in which the heating or cooling, even if essential, is merely a secondary function designed to facilitate the main mechanical function of the machine or plant, e.g., machines for coating biscuits, etc., with chocolate, and conches (heading 84.38), washing machines (heading 84.50 or 84.51), machines for spreading and tamping bituminous roadsurfacing materials (heading 84.79). … They may be heated by any system (coal, oil, gas, steam, electricity, etc.), except in the case of instantaneous water heaters and storage water heaters which are classified in heading 85.16 when heated electrically. The heading covers only nondomestic equipment, except for the instantaneous or storage water heaters referred to later in this Explanatory Note. (I) HEATING OR COOLING PLANT AND MACHINERY This group covers plant of general use in many industries for the simple treatment of materials by heating, boiling, cooking, concentration, evaporation, vaporisation, cooling, etc. They include … ... The apparatus described above is essentially used industrially, but the heading also covers nonelectric instantaneous water heaters and storage water heaters, including solar water heaters, domestic or not. If electrically heated, such appliances are excluded (heading 85.16). * * * Turning first to the classification of the HMEF, we note that the Port liquidated the HMEF under heading 5911, HTSUS, as a textile article for technical uses. Medisize entered the HMEF under heading 9019, HTSUS, as a part or accessory to respiration apparatus. Note 1(a) to Chapter 90 states that textile articles for technical uses are excluded from classification in Chapter 90. Thus, if the HMEF is prima facie classifiable under heading 5911, HTSUS, as a textile article for technical use, it cannot be classified in Chapter 90. CBP has classified similar products as textile articles of heading 5911, HTSUS. In New York Ruling Letter (NY) 852689, dated June 5, 1990, CBP classified a nonwoven textile heat and moisture exchanger of man-made fibers under heading 5911, HTSUS. Similarly, in NY A81921, dated April 16, 1996, CBP classified a textile filter element for a breathing mask under heading 5911, HTSUS. However, the textile filters in both of those cases were made up solely of textiles. The instant HMEF consists of both a textile filter and a cellulose membrane comprised of natural paper and wood pulp fibers. Articles of paper are typically classified in Chapter 48. While EN 59.11 states that certain non-textile accessories to textile articles may be classified together with the textile, Medisize claims that the cellulose membrane performs the main function of the HMEF. Namely, the cellulose membrane captures the heat and moisture exhaled by the patient and returns that heat and moisture to the patient during inhalation. The role of the textile filter is strictly for sanitary purposes. Indeed, the Medisize website advertises some heat and moisture exchangers which are only equipped with a membrane, and do not include a textile filter. See “Products: Filtration and Humidification” available at www.medisize.com. This supports Medisize’s claim that the textile filter plays a subsidiary role. Note 1(a) to Chapter 90 only excludes goods which are prima facie classifiable as textile articles of heading 5911, HTSUS. As the scope of the heading is not broad enough to encompass the textile filter, the cellulose membrane and the plastic housing shaped solely for attachment to ventilator tubing, the HMEF is not prima facie classifiable under heading 5911, HTSUS. Thus, Note 1(a) to Chapter 90 does not preclude the HMEF from classification in Chapter 90. As stated above, Medisize entered the HMEF under heading 9019, HTSUS, as a part or accessory to artificial respiration apparatus. Note 2 to Chapter 90 sets forth the rules for classifying parts and accessories in Chapter 90. Note 2(a) states that parts and accessories which are goods included in any of the headings chapter 84, 85, 90 or 91 are in all cases to be classified in their respective headings. As no single heading covers the complete HMEF, we must proceed to Note 2(b). Note 2(b) to Chapter 90 states that parts and accessories, if suitable for use solely or principally with a particular kind of machine, instrument or apparatus, are to be classified with the machines, instruments or apparatus of that kind. Heading 9019, HTSUS, provides for artificial respiration apparatus, as well as parts and accessories thereof. The medical ventilator and breathing circuit to which the HMEF attaches is a type of artificial respiration apparatus. In Rollerblade, Inc. v. United States, the U.S. Court of International Trade (CIT) sets forth the definition for an accessory to an article. 24 C.I.T. 812 (2000), aff’d by Rollerblade, Inc. v. United States, 282 F.3d 1349 (2002). The CIT cites with approval CBP Headquarters Ruling Letter (HQ) 958924, dated June 20, 1996, which states, in pertinent part, that: We, however, have repeatedly noted that an accessory is, in addition to being an article related to a primary article, is [sic in original] used solely or principally with that article. We have also noted that an accessory is not necessary to enable the goods with which they are used to fulfill their intended function. They are of secondary importance, not essential of themselves. They, however, must contribute to the effectiveness of the principal article (e.g., facilitate the use or handling of the principal article, widen the range of its uses, or improve its operation). We have also noted that Webster's Dictionary defines an accessory as an object or device that is not essential in itself but adds to the beauty, convenience, or effectiveness of something else. Id. at 816 citing Webster's New World Dictionary of the American Language 4 (2d Concise Ed. 1978). The CIT also agrees with CBP’s assertion that an "'‘[a]ccessory' is not defined as something that is merely intended to be used at the same time as something else; accessories must serve a purpose subordinate to, but also in direct relationship to the thing they 'accessorize.'" Id. at 816-817 citing Def.'s Mot. Summ. J. at 5-6 (emphasis in original). As such, an accessory must have a direct relationship to the article it accessorizes. Moreover, the accessory must serve a purpose subordinate to the article’s purpose. Finally, while an accessory is not essential to the article, it should add to the beauty, convenience or effectiveness of the article. The HMEF is solely used with the Medisize medical ventilator and breathing circuit. Moreover, the HMEF is not necessary to enable the medical ventilator and breathing circuit to function. However, the HMEF adds to the effectiveness of the breathing circuit because it simulates the function of the upper respiratory tract. Namely, the HMEF adds heat and moisture to the air inhaled by the patient. Also, the textile filter sanitizes the air flowing to the patient. For all of these reasons, we find that the HMEF is an accessory to the medical ventilator and breathing circuit. It is solely used with artificial respiration apparatus. By application of Note 2(b) to Chapter 90, the HMEF is properly classified as an accessory to artificial respiration apparatus under heading 9019, HTSUS. Turning next to the tariff classification of the heater, we note that the Port liquidated the heater entry under heading 8419, HTSUS, which provides for heating and vaporizing machinery. Medisize entered the heater under heading 9019, HTSUS, as a part or accessory to artificial respiration apparatus. Alternatively, Medisize claims in its Protest that the heater is classified in heading 9018, HTSUS, as an instrument for use in medical apparatus. Like the HMEF, the heater is solely used with the Medisize medical ventilator and breathing circuit. It heats up water to create warm vaporized air to pass through the breathing tubes to the patient. While the heater is not essential to the function of the medical ventilator and breathing circuit, it adds to the system’s effectiveness. Thus, like the HMEF, the heater is an accessory to artificial respiration apparatus. However, under Note 2(a) to Chapter 90, if the heater is prima facie classifiable as a good in the headings to Chapters 84, 85 or 91, it cannot be classified in Chapter 90. Heading 8419, HTSUS, provides, in pertinent part, for machinery for the treatment of materials by a process involving a change of temperature such as heating, or vaporizing. Heading 8516, HTSUS, provides for electric water heaters. Turning to GRI 3(a), we note that the tariff term of electric water heater is more specific than the tariff term of machinery for vaporizing or heating materials. Heading 8516, HTSUS, specifically refers to heating water, while heading 8419, HTSUS, refers to the heating and vaporizing of unnamed materials. Further, EN 84.19 states that electric water heaters of heading 85.16 are excluded from classification in heading 84.19. Thus, by application of GRI 3(a) and with support from the ENs, we find that the heater is properly classified under heading 8516, HTSUS, as an electric water heater. Electric water heaters are specifically provided for in subheading 8516.10.00, HTSUS. HOLDING: By application of GRI 1 (Note 2(b) to Chapter 90) and GRI 6, the Medisize Blue Small Heat and Moisture Exchanger/Filter (HMEF) is classified under subheading 9019.20.00, HTSUS, which provides, in pertinent part, for “[A]rtificial respiration or other therapeutic respiration apparatus; parts and accessories thereof: [A]rtificial respiration or other therapeutic respiration apparatus; parts and accessories thereof…” The 2011 column one, general rate of duty is free. By application of GRI 1 (Note 2(a) to Chapter 90), GRI 3(a) and GRI 6, the Medisize Gold heater is classified under subheading 8516.10.00, HTSUS, which provides, in pertinent part, for “Electric instantaneous or storage water heaters and immersion heaters…: Electric instantaneous or storage water heaters and immersion heaters…” The 2011 column one, general rate of duty is free. Since re-classification of the merchandise as indicated above will result in the rate of duty claimed with respect to the HMEF, and in the same rate of duty as claimed with respect to the Medisize Gold Heater, you are instructed to ALLOW the Protest in full. Duty rates are provided for your convenience and subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the World Wide Web at www.usitc.gov. You are to mail this letter together with the Customs Form 19, to the Protestant no later than 60 days from the date of this letter. Any reliquidation of the entry in accordance with the decision must be accomplished prior to mailing of the decision. Sixty days from the date of this letter, the Office of International Trade will make the decision available to CBP personnel, and to the public on the CBP Home Page on the World Wide Web at www.cbp.gov, by means of the Freedom of Information Act, and other methods of public distribution. Sincerely, Myles B. Harmon, Director Commercial Trade and Facilitation Division
Other CBP classification decisions referencing the same tariff code.