N351166

N351166 July 30, 2025 CLA-2-90:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9018.39.0040; 9018.90.8000; 9817.00.96 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 

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 fei.chen@cbp.dhs.gov. 
Sincerely,
 (for) James Forkan Acting Director National Commodity Specialist Division