BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMSafe® Pre-Filled Normal Saline Flush Syringe

    DI: 00704411009934 · Model: 1 · AMSINO INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AMSafe® Pre-Filled Normal Saline Flush Syringe
    Primary DI
    00704411009934
    Version / Model
    1
    Catalog Number
    IVF1203
    Company Name
    AMSINO INTERNATIONAL, INC.
    Labeler DUNS
    825673239
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-10
    Public Version
    2
    Public Version Date
    2022-09-09
    Public Version Status
    Update
    Public Device Record Key
    2d8a440e-2ba8-48bc-8645-c19d0753793a

    Device Description

    0.9% Sodium Chloride Injection, USP Sterile Fluid & Path Do Not Place Syringe on a Sterile Field 3 mL Fill • Preservative Free

    Device Characteristics

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NGT Saline, Vascular Access Flush

    GMDN Terms

    Code Name
    64786 Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial

    Identifiers

    Type ID
    Primary 00704411009934
    Package 30704411009935
    Package 40704411009932

    Premarket Submissions

    Submission Number Supplement Number
    K183473 000