BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ameritus

    DI: 10817522010021 · Model: 210 · KENTEC MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ameritus
    Primary DI
    10817522010021
    Version / Model
    210
    Catalog Number
    210
    Company Name
    KENTEC MEDICAL, INC.
    Labeler DUNS
    066175613
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-02
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    3f2c69a4-92c8-4902-b6e9-d99789b8b1d0

    Device Description

    ACCUTEMP DISP.SKIN PROBE#210(USE ON C100,C550) w/120P probe cover

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FMT Warmer, Infant Radiant

    GMDN Terms

    Code Name
    36989 Environmental sensor

    Identifiers

    Type ID
    Package 20817522010028
    Primary 10817522010021

    Customer Contacts

    Phone
    949-863-0810
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K960080 000