CLA-2-85:OT:RR:NC:N1:112
Todd Witkum
Sr. Import/Export Compliance Analyst, LCB
NxStage Medical, Inc.
350 Merrimack Street
Lawrence, MA 01843
RE: The tariff classification of the FW-300 NxStage Express Fluid Warmer from Mexico
Dear Mr. Witkum:
In your letter dated July 10, 2014, you requested a tariff classification ruling.
The merchandise in question is a dialysate warmer and associated tubing sets.
The first item is described as a FW-300 NxStage Express Fluid Warmer. This device is designed to warm pre-mixed bagged dialysate fluid prior to administering to a patient receiving hemodialysis treatments. The warmer is typically mounted and powered by the NxStage System One Cycler, which is a hemodialysis circuit system. The Express Fluid Warmer operates as a dry system whereby it generates heat through electric heating resistors, warming the plate surface, which allows a bag of dialysate fluid to be placed on top to be heated to specific temperatures. Dialysate fluids remain in the bag prior to treatment and at no time does the dialysate fluid come into direct contact with the surface of the warmer.
You suggested subheading 9018.90.7570, Harmonized Tariff Schedule of the United States (HTSUS), which provides for electro-medical instruments and appliances and parts and accessories thereof... other. However, dialysis fluid warmers are optional comfort devices, and being ancillary apparatus which do not perform a medical function, this subheading is not applicable.
The second item is described as Warmer Disposable Sets. A sample of the Warmer Disposable Set, which is a four-line dialysate warmer tubing assembly, was included with your request. This assembly is designed to transport bagged dialysate fluid from source bags to the Express Fluid Warmer and then to the System One Cycler. The tubing set connects multiple premixed dialysate fluid source bags to a single bag resting on the surface of the Express Fluid Warmer. From there, the warmed fluid flows into a hemodialysis dialyzer cartridge that has been mounted for use within the NxStage System One Cycler. The tubing assembly is composed of several lengths of tubing, Luer fittings, fitting caps, clamps, Y-connectors, an elbow, elbow adapter and non-vented spike. This tubing assembly is specially designed for use with the Express Fluid Warmer and is only available with a prescription.
The applicable subheading for the NxStage Express Fluid Warmer will be 8543.70.9650, HTSUS, which provides for “Electrical machines and apparatus…: Other machines and apparatus: Other: Other: Other: Other.” The general rate of duty will be 2.6%.
The applicable subheading for the Dialysate Tubing Assembly will be 9018.90.7570, HTSUS, which provides for electro-medical instruments and appliances and parts and accessories thereof... other.
Regarding these items, you have requested consideration of a secondary classification in 9817.00.96, HTSUS. HQ 964676 dated January 7, 2002 states, in part, “People who suffer from end-stage renal failure are considered handicapped, and articles specifically designed almost exclusively for their benefit are classifiable as articles for the handicapped.” Travenol Laboratories, Inc. v. United States, 813 F. Supp. 840, 844 (CIT 1993).
From the information which you have supplied regarding their construction and features, we find these items to be specially designed for use with a hemodialysis system in treatment of acute renal failure. Therefore, a secondary duty free classification will apply for the NxStage Express Fluid Warmer and the Dialysate Tubing Assemblies in 9817.00.96, HTSUS, as specially designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped (except articles for the blind).
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/.
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 Karl.Moosbrugger at [email protected].
Sincerely,
Gwenn Klein Kirschner
Director
National Commodity Specialist Division