BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Prytime Medical Devices, Inc.

    DI: 00863092000101 · Model: KT1835C · Prytime Medical Devices, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Prytime Medical Devices, Inc.
    Primary DI
    00863092000101
    Version / Model
    KT1835C
    Company Name
    Prytime Medical Devices, Inc.
    Labeler DUNS
    050741500
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-15
    Public Version
    2
    Public Version Date
    2023-01-13
    Public Version Status
    Update
    Public Device Record Key
    9784f2cc-6972-4d47-a848-0d58913180ad

    Device Description

    REBOA Catheter Convenience Set

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OFC Catheter Introducer Kit
    PXB Percutaneous Introducer Kit

    GMDN Terms

    Code Name
    58865 Vascular catheter introduction set, nonimplantable

    Identifiers

    Type ID
    Primary 00863092000101

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    20 – 25 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    excursions permitted to 15-30 degree C (59-86F); do not freeze