CLA-2-90:OT:RR:NC:N3:135
Lydia Pardini
Polsinelli Law Firm
1401 Eye Street N.W., Suite 800
Washington, DC 20005
RE: The tariff classification of feeding tubes and an extension set from Mexico
Dear Mr. Pardini:
In your letter dated July 9, 2025, you requested a tariff classification ruling on behalf of Avanos Medical Inc.
The samples were submitted, examined, and disposed of.
Four items were identified in your letter. MIC-KEY G Low-Profile Gastrostomy (G) Feeding Tube consists
of a tube, a retention balloon (inflatable balloon), a balloon cuff, and an external base (a feed head or bolster).
The external base is composed of a balloon valve, an extension set port, and a port cover. The feeding tube is
inserted into the patient’s stomach through the abdominal wall. The tube and balloon will be in the body. The
external base sits on the skin and has various sized ports to allow for various connection types including
extension tubes, or ENFit connections. The MIC-KEY G Low-Profile Gastrostomy (G) Feeding Tube is
indicated for use in patients who require long-term feeding, are unable to tolerate oral feeding, and require
gastric decompression and/or medication delivery into the stomach. The feeding tube is connected to the
MIC-KEY Extension Set (discussed below), which is used to connect a feeding tube to a feeding source.
MIC-KEY Low-Profile Gastric Jejunal (GJ) Feeding Tube is a single unit feeding/ drainage device. It enters
the stomach through a gastric stoma. The feeding tube consists of a tube, a retention balloon (inflatable
balloon), and an external bolster. The tube features internal tungsten weighting on one side for radiopacity
and to help maintain positioning and has multiple feeding exit ports (holes). The tube is held in place (within
the stoma tract) by means of the inflatable balloon and the low-profile external bolster. The external bolster
contains two ports: one labeled “JEJUNAL” and one labeled “GASTRIC.” Incorporated within each port is a
one-way valve which is opened by attaching the appropriate MIC-KEY Extension Set. MIC-KEY Extension
Sets connect to the feeding and drainage ports. The JEJUNAL port is used for feeding into the small
intestine. The GASTRIC port is used to drain the stomach with the use of low intermittent suction or gravity
drainage. A third port labeled “BAL” is used to inflate and deflate the balloon. The feeding tube provides for
simultaneous gastric decompression/ drainage and delivery of enteral nutrition into the distal duodenum or
proximal jejunum, designed for patients with complex gastrointestinal conditions necessitating simultaneous
gastric decompression and jejunal feeding.
MIC-KEY J Feeding Tube consists of a tube, a retention balloon, an external base (a feed head or bolster),
and a white radiopaque stripe along the length of the feeding tube. The external base is composed of a
balloon valve, an extension set port, and a port cover. The device is indicated for use in patients who cannot
absorb adequate nutrition through the stomach due to: intestinal motility problems, gastric outlet obstruction,
severe gastroesophageal reflux, risk of aspiration, or prior esophagectomy or gastrectomy. The feeding tube
may be placed percutaneously under fluoroscopic or endoscopic guidance or as a replacement to an existing
feeding tube using an established stoma tract.
The MIC-KEY Extension Set is designed to connect securely to the MIC-KEY Feeding Devices described
above. The Extension Sets include two feeding/medication ports with covers, a tube, a clamp, and the
patented SECUR-LOK connector (available in right-angle configurations), and are manufactured in various
lengths to accommodate patient needs. This SECUR-LOK connector connects to the extension set port in the
MIC-KEY Feeding Device base for feeding directly into the gastrointestinal areas.
You claim that the above feeding tubes and extension set are used primarily for individuals with long-term or
permanent impairments that substantially limit their ability to eat, such as those suffering from neurologic
disorders, prolonged gastrointestinal dysfunctions, and congenital or genetic disorders. You explain that the
MIC-KEY line is designed exclusively for individuals who have undergone the creation of a gastrostomy or
jejunostomy stoma, typically via endoscopic, laparoscopic, or surgical procedures. Specifically, the MIC-Key
G, GJ, and J Feeding Tubes feature a structural design contingent on the existence of a percutaneous stoma.
Each tube contains an internal retention balloon or disc and a low-profile external bolster, configured to
maintain long-term placement through the abdominal wall into the stomach or jejunum. The design also
requires a clinical or surgical procedure for placement and assumes anatomical access points that do not exist
in individuals without significant gastrointestinal impairment. Furthermore, they feature a SECUR-LOK
connector, specifically tailored for use with the MIC-KEY extension sets.
You state that the design for the Avanos Feeding Devices requires specific surgical procedures for placement,
making use by the general public improbable. The MIC-KEY line does not consist of general-use items; they
are specifically engineered to provide direct gastric access, featuring specialized materials, sizes, and
retention systems designed exclusively for patients with chronic, medically verified impairments. They are
engineered with specialized adaptations that make it suitable only for individuals with physical impairments
affecting self-feeding abilities. Able-bodied individuals would not require or benefit from such specialized
features. Avanos is a recognized and leading manufacturer and distributor of enteral feeding devices. It is the
importer of these devices. You assert that the Avanos MIC-KEY line is not sold in general consumer retail
environments – they are available by prescription through durable medical equipment providers. These items
are marketed and sold through channels that primarily serve handicapped individuals. These feeding devices
are marketed exclusively to health care providers, caregivers, rehabilitation centers, and families of disabled
individuals. You indicate that the marketing materials, user manuals, and device features all clearly target
individuals whose physical impairments substantially limit self-care abilities.
The applicable subheading for the feeding tubes will be 9018.39.0040, Harmonized Tariff Schedule of the
United States (HTSUS), which provides for “[i]nstruments and appliances used in medical, surgical, dental or
veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing
instruments; parts and accessories thereof: [s]yringes, needles, catheters, cannulae and the like; parts and
accessories thereof: [o]ther:[b]ougies, catheters, drains and sondes, and parts and accessories thereof:
[o]ther.” The general rate of duty will be free.
The MIC-KEY Extension Set is not considered a part or accessory of the feeding tube. The applicable
subheading for the item will be 9018.90.8000, HTSUS, which provides for “[i]nstruments and appliances
used in medical, surgical, dental or veterinary sciences … parts and accessories thereof: [o]ther instruments
and appliances and parts and accessories thereof: [o]ther: [o]ther.” The general rate of duty will be free.
Products of Mexico as provided by heading 9903.01.01 in Section XXII, Chapter 99, Subchapter III, U.S.
Note 2(a), HTSUS, other than products classifiable under headings 9903.01.02, 9903.01.03, 9903.01.04, and
9903.01.05, HTSUS, will be subject to an additional 25 percent ad valorem rate of duty. At the time of entry,
you must report the applicable Chapter 99 heading, i.e. 9903.01.01, in addition to subheadings 9018.39.0040
and 9018.90.8000, HTSUS, listed above. Articles that are entered free of duty under the terms of general note
11 to the HTSUS (U.S.-Mexico-Canada Agreement (USMCA)), including any treatment set forth in
subchapter XXIII of Chapter 98 and subchapter XXII of chapter 99 of the HTSUS, will not be subject to the
additional ad valorem duties provided for in heading 9903.01.01. If your product is entered duty free as
originating under the USMCA, you must report heading 9903.01.04, HTSUS, in addition to subheading 9
018.39.0040 and 9018.90.8000, HTSUS.
The additional duties imposed by heading 9903.01.01 shall not apply to goods for which entry is properly
claimed under a provision of chapter 98 of the tariff schedule pursuant to applicable regulations of U.S.
Customs and Border Protection, and whenever CBP agrees that entry under such a provision is appropriate,
except for goods entered under heading 9802.00.80; and subheadings 9802.00.40, 9802.00.50, and
9802.00.60.
Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must
be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the
Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time products from all countries
will be subject to an additional 10 percent ad valorem rate of duty. Your product falls within an excepted
subheading. At the time of entry, you must report the Chapter 99 heading applicable to your product
classification, i.e. 9903.01.27, in addition to subheadings 9018.39.0040 and 9018.90.8000, HTSUS, listed
above.
In your submission you requested consideration of a secondary classification under 9817.00.96, HTSUS,
which applies to articles and parts and accessories of articles specifically designed or adapted for the use or
benefit of the permanently or chronically physically or mentally handicapped.
Subheading 9817.00.96, HTSUS, covers: “[a]rticles specially designed or adapted for the use or benefit of the
blind or other physically or mentally handicapped persons; parts and accessories (except parts and
accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the
foregoing articles: [o]ther.” The term “blind or other physically or mentally handicapped persons” includes
“any person suffering from a permanent or chronic physical or mental impairment which substantially limits
one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing,
hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS.
Subheading 9817.00.96, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles,
dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic
articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS.
In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308
(Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent
greater than in other cases or towards others” and “designed” means something that is “done, performed, or
made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We
must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then,
whether “those persons [are] physically handicapped [].” Sigvaris, 899 F.3d at 1314.
The Court of Appeals for the Federal Circuit CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be
“specially designed,” the merchandise “must be intended for the use or benefit of a specific class of persons
to an extent greater than for the use or benefit of others” and adopted the five factors used by U.S. Customs
and Border Protection:
(1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by
properties of the design, form, and the corresponding use specific to this unique design, from articles
useful to non-handicapped persons); (2) whether any characteristics are present that create a
substantial probability of use by the chronically handicapped so that the article is easily
distinguishable from articles useful to the general public and any use thereof by the general public is
so improbable that it would be fugitive; (3) whether articles are imported by manufacturers or
distributors recognized or proven to be involved in this class or kind of articles for the handicapped;
(4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5)
whether the condition of the articles at the time of importation indicates that these articles are for the
handicapped.
Based on the information supplied, the MIC-KEY G Low-Profile Gastrostomy (G) Feeding Tube, MIC-KEY
Low-Profile Gastric Jejunal (GJ) Feeding Tube, MIC-KEY J Feeding Tube, and MIC-KEY Extension Set do
satisfy the five factors set out by CBP. As a result, it is the opinion of this office that a secondary
classification will apply in subheading 9817.00.96, HTSUS.
The tariffs and additional duties cited above are current as of this ruling’s issuance. Duty rates are provided
for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying
duty rates are provided at https://hts.usitc.gov/.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents
filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact
National Import Specialist Fei Chen at [email protected].
Sincerely,
(for)
James Forkan
Acting Director
National Commodity Specialist Division