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NY M81498

April 6, 2006

CLA-2-54:RR:NC:N3:351 M81498


TARIFF NO.: 5404.10.8080

John M. Peterson
Neville Peterson LLP
17 State Street – 19th Floor
New York, NY 10004

RE: The tariff classification of monofilament for the filtration component of oxygenator device, from Japan

Dear Mr. Peterson:

In your letter dated March 14, 2006, you requested a tariff classification ruling on behalf of your client, Terumo Cardiovascular Systems Corp., of Ann Arbor, Mich.

You submitted samples of the monofilament on a large spool. (You also submitted a cut-away cartridge housing showing the organization of the filtration component within an oxygenator reservoir, and a complete blood oxygenator device.) You state that liquefied polypropylene is extruded to form a hollow monofilament and then cooled in water to solidify the hollow form. During extrusion, seed oils are used; these oils are separated and removed during cooling, creating pores in the hollow monofilament. After cooling and drying, the monofilament is spooled and shipped to the United States.

In the U.S., the monofilament will be unwound, cut to size, and inserted into the housing of an oxygenator or similar device. The porous monofilament is used as an extracorporeal gas exchange device. The passage of gases through it provides for the oxygenation of blood during surgery.

You have not stated the decitex, but we have determined through a simple desk test that it is approximately 300. In addition, in your letter you discuss classification in heading 5404, Harmonized Tariff Schedule of the United States (HTSUS), which provides for, inter alia, synthetic monofilament of 67 decitex or more.

You have asked us to classify the monofilament on a spool in a length sufficient to make a fixed number of devices, as well as enough to make only one device. Please note that the classification of the monofilament yarn is the same regardless of the amount on the spool.

The applicable subheading for the polypropylene monofilament will be 5404.10.8080, HTSUS, which provides for "synthetic monofilament of 67 decitex or more and of which no cross-sectional dimension exceeds 1 mm; . . . monofilament: other: other." The rate of duty will be 6.9% ad valorem.

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 on World Wide Web at http://www.usitc.gov/tata/hts/.

You also state that in some cases the monofilament may feature a chemical coating (“X-coating”) that is designed to reduce the adhesion of blood platelets to the surfaces of the monofilament. Your inquiry does not provide enough information for us to give a classification ruling on the coated monofilament. Your request for a classification ruling should include a description of the coating, as well as a sample of the coated yarn. When this information is available, you may wish to consider resubmission of your request.

You propose classification in subheading 9018.90.80, HTSUS, which provides for other instruments and appliances used in medical, surgical, dental or veterinary sciences, and parts and accessories thereof. We consider the monofilament to be a material used in the making of the oxygenators; thus we do not consider the spools of monofilament themselves to be either parts or accessories for the purposes of heading 9018, HTSUS. We note the many steps necessary to be taken with the monofilament used in oxygenators as cited in Court of International Trade Slip-Op 98-16, affirmed by Court of Appeals for the Federal Circuit in 98-1343.

You propose a secondary duty-free classification in subheading 9817.00.96, HTSUS, which provides, in pertinent part, for "duty-free treatment for articles specially designed or adapted for the use or benefit of the handicapped." Oxygenators, which would be made with the type of monofilament here, were originally used exclusively for patients during surgery, which will last only hours. In those cases, the patient does not have a "physical or mental impairment" that produces the "limitation," rather the heart is deliberately stopped by the medical staff.

While it is true that similar oxygenators are now also used to a lesser extent while no surgery is being performed, this is still almost always a relatively short-term intervention to get the hospitalized patient through a crisis or until surgery can be performed. Ten days is often cited on the Internet as the longest term of use. This is quite unlike the blood dialysis equipment in Travenol, CIT Slip-Op 93-15, since dialysis treatment is often used for years to counter the effects of the sufferer's impaired kidneys and routinely enables the patient to perform many major life activities of a normal life during that period. Therefore, we do not consider oxygenators to be specially designed or adapted for the use or benefit of those "suffering from a permanent or chronic physical or mental impairment" per Chapter 98, Subchapter 17, U.S. Note 4(a), HTSUS. Further, U.S. note 4(b)(i) to that Subchapter specifically excludes "articles for acute or transient disability." Therefore, 9817.00.96, HTSUS, cannot apply to your item.

Your samples will be returned as you have requested.

This ruling is being issued under the provisions of Part 177 of the Customs 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 heading 9817, HTSUS, contact National Import Specialist J. Sheridan at 646-733-3012. If you have any other questions regarding the ruling, contact National Import Specialist Mitchel Bayer at 646-733-3102.


Robert B. Swierupski

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