NAMIC Custom Angiographic Kit

  • Model / Serial
    UPN/Material #H749601902540, and Lot/Batch # 1280052 (domestic product), Lot/Batch #s and 1275834, 1276658, and 1278843 (foreign)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including state of MO and country of Ireland.
  • Product Description
    NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds Assemblies, Product #s 40338200 and 40336200 (foreign product for further processing, e.g., packaging, labeling, sterilization, and distribution under BSC). Manufactured by: Boston Scientific Corporation/NAMIC Technology Center/Glens Falls, New York 12801. || Angiographic Manifolds are intended for use in fluid management and/or invasive pressure monitoring systems. Procedures in which angiographic manifold may be used include hemodynamic pressure monitoring and intra-arterial and intravenous administration of water based solutions or radiographic contrast media.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Navilyst Medical, 10 Glens Falls Tech Park, Glens Falls NY 12801
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    (1) Medical University of SC label: Lot 942414 (2) Covenant label: Lot 939982, 943645;  (3) St. Joseph label: Lot 940424;  (4) Spectrum label: Lot 940054 (5) Rush Foundation label: Lot 945456; 943043
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The kits were custom made and sold to consignees in IL, KY, MI, SC, and TX.
  • Product Description
    NAMIC Custom Angiographic Kit'' sold under the following labels: || (1) Medical University of South Carolina. Pouch Catalog # 60131481; || (2) Covenant Medical Center, Pouch Catalog #60131603; || (3) St. Joseph Hospital, Pouch Catalog #60101041; || (4) Spectrum Health, Pouch Catalog #61020031 || (5) Rush Foundation Hospital, Kit #65185472 ****** || Responsible firm on product labels: Boston Scientific/SCIMED *** Manufactured by: Boston Scientific Corporation / NAMIC Technology Center / Glens Falls, New York 12801. ****** || Each kit is customized to the needs of the particular hospital identified on the product labeling.
  • Manufacturer
  • Model / Serial
    Lot #990024
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    2 customers in IL and NV.
  • Product Description
    NAMIC Custom Angiographic Kit, Left Heart Kit - . Model #H749651947220. Catalog # 65194722. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Falls, NY 12801.
  • Manufacturer
  • Model / Serial
    988046
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    2 customers in IL and NV.
  • Product Description
    NAMIC Custom Angiographic Kit, Left Heart Kit. - . Model #: H7496019054110. Catalog #601905411. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Falls, NY 12801.
  • Manufacturer