CLA-2:CO:R:C:G 081132 PAM
Mr. Andrew McLaughlin
E. & A. Industries, Ltd.
Young Cove Road
Jemseg, Queens County
New Brunswick, Canada EOE 1SO
RE: Tariff classification of a certain portable dialysis fluid
warmer
Dear Mr. McLaughlin:
This is in response to your letter of August 10, 1987, in
which you request a tariff classification ruling on a certain
portable dialysis fluid warmer. Your request has been forwarded
to Headquarters for disposition. Our ruling on this merchandise
follows.
FACTS:
A sample of the X-Actemp portable electronic warmer for di-
alysis fluid was not supplied to this office. The information
accompanying your request describes that device as follows. The
electronic components, thermostat and heating elements are housed
in a molded lightweight case. The unit operates on 12 volt cur-
rent and comes equipped with a cigarette lighter plug for car
use, and an adapter for use with 110 volt wall outlets.
This portable fluid warmer is designed for use by individual
patients in unsupervised settings, like the home, car, office,
etc. The electric heating circuitry is not removable from the
fitted case.
ISSUE:
Are portable dialysis fluid warming devices classified under
the provision for other electrical machines and apparatus, other,
in subheading 8543.80.9080, Harmonized Tariff Schedule of the
United States Annotated (HTSUSA).
-2-
LAW AND ANALYSIS:
The dialysis fluid warmer is designed to be a portable elec-
trical machine or apparatus. It is intended for use in various
locations, e.g., in automobiles, households, or offices. The use
of 12 volt electric current to power this item is indicative of
its intended use by patients as a portable, individualized unit
in a variety of unsupervised settings.
The Explanatory Note E to Section XVI, Chapter 85.16, indi-
cates that the term electro-thermic refers to appliances and ma-
chines which are "normally used in the household." That note in-
cludes a list of such appliances. Included in this list are
items like toasters, waffle irons, saute pans, face dryers, bed
warmers, yogurt and cheese makers and popcorn cookers. The di-
alysis fluid warmer is dissimilar from any of the enumerated ar-
ticles. It is also not designed to be "normally used in the
household."
The Explanatory Notes to Section XVIII, Chapter 90.18, state
in pertinent part that:
This heading covers a very wide range of
instruments and appliances which, in the
majority of cases, are used only in profes-
sional practice (e.g., by doctors, surgeons,
dentists, veterinary surgeons, midwives), ei-
ther to make a diagnosis, to prevent or treat
an illness or to operate, etc.
* * *
On the other hand, this heading includes
specialized measuring instruments used exclu-
sively in professional practice, such as
cephalometers, dividers for measuring cerebral
lesions, obstetrical pelvimeters, etc.
* * *
Dialysis warmers are ancillary apparatus which do not
perform a medical function. The dialysis fluid warmed by these
machines is introduced into the body cavity through a catheter in
the patient's side and, after several hours, the fluid is removed
by siphoning. Gravity is used to draw the fluid through the
catheter and into the body cavity. The empty bag is then placed
on the floor, and the fluid flows out of the body cavity and back
into the bag.
-3-
While in the body cavity, a gradient in the fluid pulls out
waste through small blood vessels. Once removed or siphoned from
the body cavity this fluid is discarded. This operation,
referred to as peritoneal dialysis, gets its name from the
membrane lining the walls of the abdominal cavity and enclosing
the viscera called the peritoneum.
It is not necessary that the dialysis fluid be warmed before
being introduced into the patient's body cavity. Cold fluid has
the effect of lowering the body temperature for a short time.
Patients are given instructions along with the dialysis fluid and
these instructions indicate that fluid may be warmed if a patient
so chooses. A microwave oven or heating pad can be used to warm
the fluid; the main concern being that hot fluid could damage a
patient's internal organs. Whether or not a patient chooses to
warm fluid is also affected by the seasons. Generally speaking,
during warm summer months fluid is never warmed.
Under the HTSUSA, Additional U.S. Rule of Interpretation
1.(a) provides that "a tariff classification controlled by use
(other than actual use) is to be determined in accordance with
the use in the United States at, or immediately prior to, the
date of importation, of goods of that class or kind to which the
imported goods belong, and the controlling use is the principal
use." Therefore, the classification of merchandise as electro-
medical apparatus under the HTSUSA must be supported by evidence
demonstrating that the merchandise belongs to the class or kind
of apparatus principally used by physicians in the practice of
medicine involving the diagnosis, treatment or prevention of
illness or disease. No such evidence exists with regard to the
dialysis fluid warmer now under consideration.
The dialysis fluid warmer is apparently designed, marketed,
sold, and intended for use by patients in unsupervised settings.
Evidence indicates that the device is ordered direct from the
manufacturer by mail. The warmer is designed for use in
automobiles, offices, and the home. It is run from a 12 volt
power supply, like that found in cars and boats, but is adaptable
for use with 120 volt outlets. The casing in which the unit is
permanently housed is constructed to give the outward appearance
of a briefcase, and the unit is intended to provide the user with
"convenience, comfort and peace of mind." To this end, the X-
Actemp is equipped with an electronic thermostat that allows the
user to adjust the final temperature of the fluid to his or her
own preference. Since the X-Actemp functions solely as a warming
unit for dialysis fluid, and the patient is given control over
the temperature of that fluid, we consider it to be designed for
use by individual patients, and not for the use or convenience of
medical practitioners in the diagnosis, treatment or prevention
of illness or disease.
-4-
HOLDING:
For the reasons stated above, this portable electric
dialysis fluid warmer (the X-Actemp) is classified under the
HTSUSA provision in subheading 8543.80.9080, which covers other
electrical machines and apparatus, dutiable at the rate of 3.9
percent ad valorem. This classification represents the present
position of the Customs Service regarding the dutiable status of
the merchandise under the proposed HTSUSA. If there are changes
before enactment this advice may not continue to be applicable.
The applicable item number from the Tariff Schedules of the
United States (TSUS) is 688.42 which covers electrical articles,
not specially provided for, dutiable at the rate of 3.9 percent
ad valorem.
Sincerely,
John Durant, Director
Commercial Rulings Division
6cc: Area Director, New York Seaport
1cc: Area Director, Newark
2cc: Chief, CIE
1cc: John Durant
PAMartin: