CLA-2 CO:R:C:G 085088 JMH
Herbert J. Lynch, Esq.
Sullivan & Lynch
156 State Street
Boston, Massachusetts 02109
RE: Fistula needle set and I.V. administration set
Dear Mr. Lynch:
Your October 24, 1988, letter requesting a classification
ruling under the Harmonized Tariff Schedule of the United States
Annotated (HTSUSA) for fistula needle sets and I.V.
administration sets on behalf of National Medical Care, Inc. has
been referred to this office for a reply.
FACTS:
The articles in question are A.V. Fistula Needle Sets and
I.V. Administration Sets. Both items are to be imported from
Japan or Singapore.
The Fistula Needle Set consists of a 4-12 inch plastic tube
which is fitted at one end with a 14-17 gauge, 1-1&1/2 inch
stainless steel needle, needle guard and stabilizer, and fitted
at the other end with a protective cap. Options for the set
include backeyes, rotatable hubs and clamps. This apparatus is
used clinically for the intravenous application of medication,
blood serum, glucose solution, and sodium chloride solution. The
device is used in gaining access to a patient's circulatory
system.
The I.V. Administration Set consists of 48 inches of plastic
tubing, with a drip chamber and spike at one end and a needle
adapter with a protective covering at the other end. The article
also has a clamp attached to the plastic tubing. I.V.
Administration Sets are used for the intravenous application of
medication, blood serum, glucose solution, and sodium chloride
solution.
-2-
ISSUE:
Issue 1: What is the appropriate classification under the
HTSUSA for the A.V. Fistula Needle Set?
Issue 2: What is the appropriate classification under the
HTSUSA for the I.V. Administration Sets?
LAW AND ANALYSIS:
The classification of merchandise under the HTSUSA is
governed by the General Rules of Interpretation (GRI's). GRI 1,
HTSUSA, states in part that "for legal purposes, classification
shall be determined according to the terms of the headings and
any relative section or chapter notes..."
Issue 1
The appropriate classification, according to the terms of
the headings, for the fistula needle set is within subheading
9018.39.00, HTSUSA. This subheading describes:
9018 Instruments and appliances used in medical,
surgical, dental or veterinary sciences....
9018.39.00 Syringes, needles, catheters, cannulae
and the like; parts and accessories
thereof...Other...
Dorland's Illustrated Medical Dictionary defines a cannula
as "a tube for insertion into a duct or cavity; during insertion
its lumen (cavity or channel within a tube or tubular organ) is
usually occupied by a trocar (a sharp pointed instrument...used
to puncture the wall of a body cavity...)." Dorland's Illustrated
Medical Dictionary, pp. 262, 956, 1760 (1988). A catheter is
defined as "a tubular, flexible, surgical instrument for
withdrawing fluids from (or introducing fluids into) a cavity of
the body..." Dorland's Illustrated Medical Dictionary, p. 284.
Fistula is defined as "an abnormal passage or communication,
usually between two internal organs, or leading from an internal
organ to the surface of the body..." Dorland's Illustrated
Medical Dictionary, p. 635 (1988).
The subject fistula needle set is a small, flexible, plastic
tube inserted into a body cavity (a blood vessel) by a sharp
pointed instrument (a needle). The tube acts as an abnormal
passage from the blood vessel to the body surface. It allows
blood or other fluids to enter or leave the vessel. Therefore,
the fistula needle sets, by definition, are similar to "needles,
catheters, cannulae and the like..." and properly classified
within subheading 9018.39.00.
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Issue 2
You contend that the I.V. Administration Set is a "necessary
and integral component in hemodialysis", and therefore, properly
classified within subheading 9018.90.70203, HTSUSA, as "Electro-
medical instruments and appliances and parts and accessories
thereof...Other...Dialysis instruments and apparatus..." The
provision for "dialysis instruments and apparatus" is a
statistical breakout and can only be reached if the superior
subheading for electro-medical instruments is reached.
The I.V. Administration Set in question is not an electro-
medical instrument or appliance, since it does not operate by
using electricity. Since the electrical functioning of a
dialysis machine does not depend upon the use of an I.V.
Administration Set, the I.V. Administration Set is not a part of
such a machine. Nor is the I.V. Administration Set an accessory
of an electro-medical instrument, since the set does not
supplement or assist the functioning of the machine. An I.V.
Administration Set is merely the disposable conduit through
which blood flows between the patient and the machine. The set
is used once and then thrown away. Such a conveyance system is
not a part or an accessory.
The I.V. Administration Set is not an electro-medical
apparatus, nor is it a part or an accessory of such an
instrument. Therefore, the appropriate classificatin of the I.V.
administration set is within subheading 9018.90.80, HTSUSA, as
"Instruments and appliances used in medical, surgical, dental and
veterinary sciences...Other instruments and appliances and parts
and accessories thereof...Other..."
HOLDING:
The Fistula Needle Sets imported from Japan and Singapore
are properly classified within subheading 9018.39.00, HTSUSA, as
"Instruments and appliances used in medical, surgical, dental or
veterinary sciences....Syringes, needles, catheters, cannulae and
the like; parts and accessories thereof...Other..."
The I.V. Administration Sets imported from Japan and
Singapore are properly classified within subheading 9018.90.80,
HTSUSA, as "Instruments and appliances used in medical, surgical,
dental and veterinary sciences...Other instruments and appliances
and parts and accessories thereof...Other..."
Sincerely,
John Durant, Director
Commercial Rulings Division