BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    System Destination Kit, ALS CE

    DI: 00852184003076 · Model: 20-0064 · Synapse Biomedical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    System Destination Kit, ALS CE
    Primary DI
    00852184003076
    Version / Model
    20-0064
    Company Name
    Synapse Biomedical, Inc.
    Labeler DUNS
    138432070
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    8638c8dc-f3b7-48c6-8793-5076932341dc

    Device Characteristics

    Single Use
    No
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OIR Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

    GMDN Terms

    Code Name
    47808 Intramuscular diaphragm/phrenic nerve electrical stimulation system

    Identifiers

    Type ID
    Primary 00852184003076