BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AmnioTest Colour Cards

    DI: 10628429001254 · Model: PL.902 · PRO-LAB, INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AmnioTest Colour Cards
    Primary DI
    10628429001254
    Version / Model
    PL.902
    Catalog Number
    PL.902
    Company Name
    PRO-LAB, INCORPORATED
    Labeler DUNS
    960418395
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-26
    Public Version
    1
    Public Version Date
    2023-01-03
    Public Version Status
    New
    Public Device Record Key
    61cf6649-a1fd-46f2-b3be-e4cfa8e7a6bd

    Device Description

    AmnioTestTM is designed to assist in the detection of rupture of the fetal membrane. It offers the most efficient, cost effective, reliable, and simple to use point-of-care screen test to aid in the detection of amniotic fluid in near-term patients. Along with a simple quality control regimen, AmnioTestTM is an invaluable tool for OB-GYN and L+D clinics. 50 cards

    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
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HIO Sampler, Amniotic Fluid (Amniocentesis Tray)

    GMDN Terms

    Code Name
    65199 Amniotic fluid leak detector

    Identifiers

    Type ID
    Primary 10628429001254