CLA-2-90:OT:RR:NC:4:405

Mr. Jay Mittleman
Kinetic Concepts, Inc.
P.O. Box 659508
San Antonio, TX 78265-9508

RE: The tariff classification of Vacuum Assisted Closure Therapy disposable kit from Mexico

Dear Mr. Mittleman:

In your letter to Regulations and Rulings in Washington, DC, dated September 20, 2010, for Kinetic Concepts, Inc. (KCI), you requested a tariff classification ruling. Three samples were provided. Along with other documentation, you also included the 84 page K.C.I. booklet, V.A.C. Therapy Clinical Guidelines, A Reference Source for Clinicians.

The samples are the M627052, M8275099, and PRE1055.

VAC therapy is typically used by medical professionals in the management of severe wounds/incisions and uses an electric suction pump with a storage container to assist in the removal of wound fluids and in keeping the wound from opening.

Each sample consists of a sealed, sterile pouch, relatively flat and roughly about 1 foot by 1 foot, which contains a plastic foam dressing (to be placed directly over the wound), an acrylic drape for holding the foam dressing in place, a length of relatively narrow plastic tubing, a plastic device to spread the area of the suction, and a plastic connector to the pump inlet.

You propose classification in HTSUS heading 3005. However, the Vacuum Assisted Closure (V.A.C.) dressings are designed for use exclusively with the KCI V.A.C® Therapy Systems. The Prevena™ dressings are designed for use with the KCI Prevena™ 125 Therapy Unit. These products are intended to help manage the environment of wounds or surgical incisions by the application of negative pressure. The open cells of the foam dressings enable distribution of the negative pressure across the wound surface while the SensaT.R.A.C ® Pad and Tubing transfer accumulated exudate to the canister. The SensaT.R.A.C.® pad distributes negative pressure to individual sensing lumens and  helps reduce tubing blocks and false alarms through enhanced fluid dynamics. The SensaT.R.A.C.® Tubing draws exudate away from the wound larger lumen, monitors target pressure at the wound through the outer sensing lumens, and allows for secure and convenient tubing connections. The dressings are not designed to be applied or left in place without V.A.C.® Therapy being active.

It is the opinion of this office that these specialized products have no use as dressings outside the confines of the V.A.C® Therapy Systems. They have no function without the pad, the tube, and, ultimately, the monitor and canister. They are single-use disposable components of the V.A.C® Therapy Systems. They do not strictly meet the parameters of heading 3005

The suction pump/canister apparatus that these are used with is classifiable in HTSUS 9018.90.75. Although they work by creating a partial vacuum, HTSUS Note 1-d to Chapter 85 states that it does not cover “Vacuum apparatus of a kind used in medical, surgical, dental or veterinary purposes (Chapter 90).” The suction pump/canister is of no use without one of your imports or similar.

While several components, imported separately, would likely not be classified as parts or accessories of the suction pump/canister due to HTSUS Additional U.S. Rule of Interpretation 1-c, that is the only description that applies to all the non-subordinate elements in your import. See Court of Appeals for the Federal Circuit 00-1263, General Electric Company-Medical Systems Group v. United States.

The applicable subheading for the three samples will be 9018.90.7580, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "other" Electro-medical instruments and appliances and parts and accessories thereof. The rate of duty will be free.

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 specifically regarding classification in HTSUS 3005, contact National Import Specialist H. Kuperstein at (646) 733-3033. If you have any other questions regarding the ruling, contact National Import Specialist J. Sheridan at (646) 733-3012.

Sincerely,

Robert B. Swierupski
Director
National Commodity Specialist Division