CLA-2-85:OT:RR:NC:N1:109

Sunny Kim
Compliance Analyst
James J. Boyle and Co.
1200 Corporate Center Dr.
Suite 350
Monterey Park, CA 91754

RE: The tariff classification of a Cardio Messenger device and a Catheter Guide Wire from Germany and Switzerland

Dear Ms. Kim:

In your letter dated February 21, 2013, you requested a tariff classification ruling on behalf of your client, Biotronik, Inc.

The first item concerned is referred to as the Cardio Messenger II-S (Model # 362444). This is a small external device that receives data from an implanted (within the chest of a patient) cardiac device (ICD), such as a pacemaker or defibrillator. It receives a whole spectrum of data from the ICD and forwards that information to a “Home Monitoring Service” through the use of the cellular telephone network. It’s a bedside home monitoring system that is used to send daily reports from a patient’s ICD to their physician through the monitoring service provider. The patient must be within six feet of the Cardio Messenger to facilitate the daily reception and transmission of data. (Please see N201417).

Regarding the Cardio Messenger II-S, you propose classification under HTSUS 9018.19.95 as Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters) and parts and accessories thereof – Patient Monitoring Systems. However, as discussed in Headquarters Ruling Letter 961998, dated May 7, 1999, that subheading is intended for apparatus which themselves measure several of the patient’s “vital signs,” such as respiration rate and blood pressure and then display that information. This item primarily relays telephonically, on a regular basis, the data transmitted to it by one of various models of Implantable Cardioverter-Defibrillators or Pacemakers, primarily concerning the implant’s own activity and status. While it is identifiable as suitable for use solely or principally with those implanted devices, which are classified in HTSUS 9021, Note 2-a to HTSUS Chapter 90 excludes, in all cases, parts or accessories which are, in themselves, included in any of the headings of Chapter 84, et al. Also, Harmonized System General Explanatory Note IV to Chapter 90 indicates that the transmitting elements of telemetry systems are not classified in Chapter 90 when imported separately from the apparatus that performs the measurement, etc.

The applicable subheading for the Cardio Messenger II-S (Model # 362444) will be 8517.62.0050, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Machines for the reception, conversion and transmission or regeneration of voice, images, or other data…:. The rate of duty will be Free.

The second item concerned is the Galeo S 014 catheter guide wire. This is a stainless steel guide wire that is used to facilitate the positioning of an electrical lead for pacemakers.

Regarding the Galeo S 014, a stainless steel catheter guide wire, you propose classification in HTSUS 9018.39.0040. However, consistent with New York Ruling Letter N202857, dated February 24, 2012, we believe Statistical Suffix 50 is more appropriate for Guide Wires than Statistical Suffix 40.

The applicable subheading for the Galeo S 014 will be 9018.39.0050, HTSUS, which provides for instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments: parts and accessories: syringes, needles, catheters, cannulae and the like; parts and accessories thereof; other. The rate of duty will be Free.

In your submission you asked about the possible applicability of a secondary classification for these items in HTSUS 9817.00.96 as articles for the handicapped. From the information you have supplied, they are specially designed for use in inserting leads or forwarding information for implanted pacemakers/defibrillators. A secondary classification for these items will apply in HTSUS 9817.00.96 as specially designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped (except articles for the blind). Note that the requirement that you prepare and file a U.S. Department of Commerce form ITA-362P has been eliminated via a notice from the International Trade Administration, published in the Federal Register of June 1, 2010. This merchandise is already duty free, but if you elect to claim the secondary classification in Chapter 98 of 9817.00.96 and meet the entry requirements, no merchandise processing fee will apply to those importations even if they are non-NAFTA, noting, e.g., Headquarters Ruling Letter 229110 IDL, 8-29-02. Also note that this classification has no effect on any quota, visa, or restricted merchandise requirements or any dumping or countervailing duties. 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 headings 9018 or 9817, please contact NIS James Sheridan at (646) 733-3012. For all other issues please contact National Import Specialist Steven Pollichino at (646) 733-3008.

Sincerely,

Thomas J. Russo
Director
National Commodity Specialist Division