CLA-2-84:OT:RR:NC:N1:105
Steven Zisser
Zisser Customs Law Group
9355 Airway Rd. ,Suite 1 San Diego, CA 92154 United States
RE: The tariff classification of the LINX145 Water Pre-Treatment System from China
Dear Mr. Zisser:
In your letter dated January 3, 2023, on behalf of your client, NxStage Medical Inc., you requested a tariff classification ruling.
The item under consideration is the LINX Water Pre-Treatment System (model number LINX145), which is a filtering system designed to reduce the hardness and level of chemical contaminants (known as total dissolved solids or TDS), as well as trap suspended solids from source water. The LINX145 model is designed specifically for use with the NxStage PureFlow SL System and is sold exclusively by NxStage.
The System One with PureFlow SL is part of NxStage’s Home Hemodialysis (HHD) systems designed to yield AAMI/ANSI/ ISO quality water and dialysate for in-center and home use. The first part of the system is the System One Cycler, which is the portable home dialysis machine that contains the fluid pumps and system controls. The second part of the system is the PureFlow SL Dialysate Preparation System (PFSL), which produces purified product water from ordinary tap water. This water is then mixed with sterile filtered dialysate concentrate to produce AAMI-quality dialysate fluid. The PFSL then transfers the produced dialysate fluid via connected tubing to the System One Cycler. The third part of the system is the LINX145 Water Pre-Treatment System subject to this ruling.
Prior to the set up and installation of NxStage’s Home Hemodialysis System, the patient’s source water is tested and evaluated to see if it meets specific standards. If the source water does not pass the test and results in high TDS and hardness (calcium, magnesium), NxStage issues the LINX145 System for the patient to use in conjunction with the PureFlow SL and System One Cycler. In this case, the complete HHD System consists of all 3 modules. If the PureFlow SL and the System One Cycler have an adequate water source, then the LINX145 is not required and the remaining components can function as intended.
In operation, the LINX145 System connects directly to the external water supply source. The tap water is treated by the LINX System to create ultra-pure de-ionized water. The pure de-ionized water is then fed to the PureFlow SL to be added to the dialysate concentrate. The untreated water is then discarded separately via the drain line. The LINX145 System uses two types of filters to treat and remove the TDS from water. The first involves two deionization (DI) cells located on the top of the unit. The second is the two five-micron sediment filters found inside the plastic cabinet of the “LINX System” unit. One sediment filter is located before the cells while the second sediment filter is located after the DI cells.
The LINX145 System has been customized for use specifically with the PureFlow SL Dialysate Preparation System and is substantially different than the LINX140 model commercially available to the public. A special flow sensor that automatically senses the water demand from the PureFlow SL has been added to the LINX145 system. Once the sensor detects that the PureFlow SL is low on water, it will automatically trigger the LINX System to start purifying water for the PFSL to use in its next batch. There is also a continuous water supply feature. Having a continuous water supply provides the PureFlow SL a constant stream and access to water, which is an essential feature to the PFSL and the Home Hemodialysis System. Additionally, a dedicated downstream port connection allows the direct attachment of the LINX System to the PFSL allowing the filtered source water to travel from one system to the other. The LINX145 cannot be connected or attached to another device or system. Finally, a Dial-A-Taste control feature is specifically removed for the LINX145 system. The Dial-A-Taste control allows the user to customize the taste of the drinking water by choosing spring water, drinking water, or purified water flavor. The LINX145 System’s exclusive use does not require these settings.
The applicable subheading for the LINX Water Pre-Treatment System (model number LINX145) will be 8421.21.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Centrifuges, including centrifugal dryers; filtering or purifying machinery and apparatus, for liquids or gases; parts thereof: Filtering or purifying machinery and apparatus for liquids: For filtering or purifying water.” The general rate of duty will be free.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 8421.21.0000, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.01, in addition to subheading 8421.21.0000, HTSUS, listed above. The HTSUS is subject to periodic amendment so you should exercise reasonable care in monitoring the status of goods covered by the Note cited above and the applicable Chapter 99 subheading. For background information regarding the trade remedy initiated pursuant to Section 301 of the Trade Act of 1974, you may refer to the relevant parts of the USTR and CBP websites, which are available at https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions and https://www.cbp.gov/trade/remedies/301-certain-products-china respectively.
In your request, you ask if the LINX Water Pre-Treatment System (model number LINX145) is “eligible for importation under the Nairobi Protocol SPI.” The United States, one of the signatories, has implemented part of the United Nations Nairobi Protocol, currently, via a provision for a secondary classification for articles for the handicapped in HTSUS 9817.00.92 through .96 and US Note 4 to Subpart 17 to Chapter 98. From the information provided, the LINX Water Pre-Treatment System (model number LINX145) makes the home dialysis machine safe for use in a home setting. It is an article specially designed for the benefit of the handicapped, and the LINX Water Pre-Treatment System in question is specially designed or adapted for use with the home dialysis machine. Based on the information supplied, it is the opinion of this office that a secondary classification will apply for the LINX Water Pre-Treatment System (model number LINX145) in subheading 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), free of duty and user fees (if any). Note that the requirement that the importer 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. Also note that this classification has no effect on any quota, visa, or restricted merchandise requirements or countervailing or dumping duties. 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.
Please note that the additional duties imposed by headings 9903.88.01, 9903.88.02, 9903.88.03, and 9903.88.04 do not apply to goods for which entry is properly claimed under a provision of chapter 98 of the HTSUS, except for goods entered under headings 9802.00.40, 9802.00.50, 9802.00.60, and 9802.00.80. For headings 9802.00.40, 9802.00.50, and 9802.00.60, the additional duties apply to the value of repairs, alterations, or processing performed abroad, as described in the applicable heading. For heading 9802.00.80, the additional duties apply to the value of the article less the cost or value of such products of the United States, as described in heading 9802.00.80.
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 at https://hts.usitc.gov/current
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection 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, please contact National Import Specialist Jason Christie at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division