BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Voyager Infant Transport Incubator

    DI: 00865648000320 · Model: Voyager · INTERNATIONAL BIOMEDICAL, LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Voyager Infant Transport Incubator
    Primary DI
    00865648000320
    Version / Model
    Voyager
    Company Name
    INTERNATIONAL BIOMEDICAL, LTD.
    Labeler DUNS
    073179368
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-20
    Public Version
    1
    Public Version Date
    2023-06-28
    Public Version Status
    New
    Public Device Record Key
    0e10223b-5de3-42a2-be5d-cf30cdc73f4c

    Device Description

    Voyager Infant Transport Incubator

    Device Characteristics

    Single Use
    No
    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FPL Incubator, Neonatal Transport

    GMDN Terms

    Code Name
    35121 Transport infant incubator

    Identifiers

    Type ID
    Primary 00865648000320

    Customer Contacts

    Phone
    5128730033
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K022876 000