BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ambIT

    DI: 00857595005725 · Model: 220523 · SUMMIT MEDICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ambIT
    Primary DI
    00857595005725
    Version / Model
    220523
    Catalog Number
    220523
    Company Name
    SUMMIT MEDICAL PRODUCTS, INC.
    Labeler DUNS
    831704841
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-01-03
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    58a71665-9ccb-4821-9aaf-8303fd29de00

    Device Description

    Cassette - Filter, Male Neuraxial Connector

    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
    MR Unsafe
    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
    FRN Pump, Infusion
    MEA Pump, Infusion, Pca

    GMDN Terms

    Code Name
    35833 Electric infusion pump administration set, single-use

    Identifiers

    Type ID
    Package 20857595005729
    Package 10857595005722
    Primary 00857595005725

    Customer Contacts

    Phone
    801-352-1888
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -25 – 70 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    -25 – 70 Degrees Celsius