BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Comfort Sampler

    DI: 00894472000138 · Model: 1 · OPTI MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Comfort Sampler
    Primary DI
    00894472000138
    Version / Model
    1
    Catalog Number
    BP0600
    Company Name
    OPTI MEDICAL SYSTEMS, INC.
    Labeler DUNS
    801458279
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-06
    Public Version
    1
    Public Version Date
    2019-08-14
    Public Version Status
    New
    Public Device Record Key
    4abe6d79-bfc7-48ac-8096-ae8a112561d7

    Device Description

    Comfort Sampler, Arterial Blood Sampler

    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
    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
    CBT Arterial Blood Sampling Kit

    GMDN Terms

    Code Name
    31336 Arterial blood sampling kit

    Identifiers

    Type ID
    Primary 00894472000138