BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Bioseal Inc.

    DI: 00630094960227 · Model: 19602S/20 · BIOSEAL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bioseal Inc.
    Primary DI
    00630094960227
    Version / Model
    19602S/20
    Company Name
    BIOSEAL
    Labeler DUNS
    186968939
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-19
    Public Version
    1
    Public Version Date
    2023-10-27
    Public Version Status
    New
    Public Device Record Key
    7a6c44b0-f7ad-453d-9e2f-453a660f3147

    Device Description

    Silicone Tubing Set 7' w/Connector

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GCY APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

    GMDN Terms

    Code Name
    60538 Luer/Luer linear connector, single-use

    Identifiers

    Type ID
    Package 10630094960224
    Primary 00630094960227