BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TC 560 Contact Liquid

    DI: 07332834000264 · Model: TC 560 · Perimed AB
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TC 560 Contact Liquid
    Primary DI
    07332834000264
    Version / Model
    TC 560
    Company Name
    Perimed AB
    Labeler DUNS
    354765570
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-13
    Public Version
    5
    Public Version Date
    2023-05-08
    Public Version Status
    Update
    Public Device Record Key
    796227bc-964e-458f-bd3a-809877d1b3f6

    Device Description

    TC 560 Contact Liquid (20 ml)

    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
    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
    KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
    LKD Monitor, Carbon-Dioxide, Cutaneous

    GMDN Terms

    Code Name
    46934 Transcutaneous blood gas monitoring system

    Identifiers

    Type ID
    Primary 07332834000264

    Premarket Submissions

    Submission Number Supplement Number
    K990960 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    5 – 30 Degrees Celsius