The tariff classification of PhaSeal drug delivery system from Sweden.
Issued December 29, 2011 by U.S. Customs and Border Protection.
Tariff classification
HTS codes: 9018.90.8000
Headings: 9018
Product description
The sample was not sent in the sterile retail packaging, but each of the components are attached to a board and labeled for identification. The merchandise in question, the PhaSeal drug delivery system, is used by medical professionals to deliver hazardous drugs to patients. The system consists of four components; the Protector, the Assembly Fixture, the Injector Luer Lock, and the Connector. The Protector is a sealed, airtight, pressure equalizing expansion chamber that is permanently attached to the vial containing the drug. It ensures that there is neither overpressure nor vacuum when air or fluid is injected into, or aspirated from the vial. The Assembly Fixture attaches the Protector onto the vial containing the drugs in preparation for use. The Injector Luer Lock attaches to a syringe or IV line to create a closed drug transfer conduit. It has a stainless steel cannula. The Connector is the access port that attaches to the standard Luer Lock in an intravenous line. It creates a leak proof seal throughout the entire drug transfer procedure. The Infusion Adapter can be used in place of the Connector when the drug is administered via an IV pump set. The Infusion Adapter contains a built-in connector. The components are imported in a sterile condition and each component is an integral part of the system. The PhaSeal system is used by medical practitioners in a hospital setting to administer chemotherapy or other potentially hazardous drugs between a vial and a syringe or an IV bag. The closed delivery system is uniquely designed to protect healthcare workers who administer these drugs. The importer will use the spike in the Infusion Adaptor only in the cases in which the transfer is from the vial to an IV bag. The drug in the vial can be mixed or diluted as well as being transferred unchanged. The import is used in conjunction with a standard, disposable syringe, which is not part of the import. We agree that
CBP rationale
the applicable subheading for the PhaSeal drug delivery system will be 9018.90.8000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "other" instruments and apparatus used in medical, surgical, dental, or veterinary sciences, and parts and accessories thereof.
Full text
N196255 December 29, 2011 CLA-2-90:OT:RR:NC:N4:405 CATEGORY: Classification TARIFF NO.: 9018.90.8000 Eleanore Kelly-Kobayashi Rode & Qualey, Attorneys at Law 55 West 39th Street New York, NY 10018 RE: The tariff classification of PhaSeal drug delivery system from Sweden. Dear Ms. Kelly-Kobayashi: In your letter dated, November 7, 2011, received on December 8, 2011, on behalf of Becton, Dickinson and Company, you requested a tariff classification ruling. A sample was provided. The sample was not sent in the sterile retail packaging, but each of the components are attached to a board and labeled for identification. The merchandise in question, the PhaSeal drug delivery system, is used by medical professionals to deliver hazardous drugs to patients. The system consists of four components; the Protector, the Assembly Fixture, the Injector Luer Lock, and the Connector. The Protector is a sealed, airtight, pressure equalizing expansion chamber that is permanently attached to the vial containing the drug. It ensures that there is neither overpressure nor vacuum when air or fluid is injected into, or aspirated from the vial. The Assembly Fixture attaches the Protector onto the vial containing the drugs in preparation for use. The Injector Luer Lock attaches to a syringe or IV line to create a closed drug transfer conduit. It has a stainless steel cannula. The Connector is the access port that attaches to the standard Luer Lock in an intravenous line. It creates a leak proof seal throughout the entire drug transfer procedure. The Infusion Adapter can be used in place of the Connector when the drug is administered via an IV pump set. The Infusion Adapter contains a built-in connector. The components are imported in a sterile condition and each component is an integral part of the system. The PhaSeal system is used by medical practitioners in a hospital setting to administer chemotherapy or other potentially hazardous drugs between a vial and a syringe or an IV bag. The closed delivery system is uniquely designed to protect healthcare workers who administer these drugs. The importer will use the spike in the Infusion Adaptor only in the cases in which the transfer is from the vial to an IV bag. The drug in the vial can be mixed or diluted as well as being transferred unchanged. The import is used in conjunction with a standard, disposable syringe, which is not part of the import. We agree that the applicable subheading for the PhaSeal drug delivery system will be 9018.90.8000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "other" instruments and apparatus used in medical, surgical, dental, or veterinary sciences, 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 regarding the ruling, contact National Import Specialist J. Sheridan at (646) 733-3012. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division
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