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NY I84690




August 7, 2002

CLA-2-30:RR:NC:2:238 I84690

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.90.9170

Ms. Joni Post
Gambro Renal Products
10810 W. Collins Avenue
Lakewood, CO 80215

RE: The tariff classification of PrismaSate BK0/3 and PrismaSate BK2/0 sterile bicarbonate-buffered dialysates from Italy

Dear Ms. Post:

In your letter dated July 22, 2002, you requested a tariff classification ruling.

The subject products, PrismaSate BK0/3 and PrismaSate BK2/0, each consist of a clear, plastic bag, divided into two separate compartments, the upper (smaller) compartment (compartment “A”) containing 250 ml of a sterile electrolyte solution, and the lower (larger) compartment (compartment “B”) containing 4750 ml of a sterile buffer solution. These dual-compartment bags, housing the electrolyte and buffer solutions in separate compartments (i.e., the non-reconstituted solution), represent the actual imported products, and are referred to in the descriptive literature submitted with your letter as “The non-reconstituted PrismaSate dialysate bag(s) .” Subsequent to importation, and prior to actual use, the reconstituted solution (totaling 5000 ml) is prepared by breaking the frangible pin situated between the two compartments, allowing for the - mandatory - mixing of the two solutions. The reconstituted dialysate is then ready for infusion, via a port on the bottom of the plastic bag, into the apparatus that performs the actual dialysis.

The applicable subheading for the subject products will be 3004.90.9170, Harmonized Tariff Schedule of the United States (HTS), which provides for “Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other: Other: Preparations primarily affecting the electrolytic, caloric or water balance: Other.” The rate of duty will be free. This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.

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 the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033.

Sincerely,

Robert B. Swierupski

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