BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Bio-Probe®

    DI: 00673978563336 · Model: CB4627 · MEDTRONIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Bio-Probe®
    Primary DI
    00673978563336
    Version / Model
    CB4627
    Company Name
    MEDTRONIC, INC.
    Labeler DUNS
    006261481
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-16
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    ddebdaf5-01a6-4f3b-bac6-7277f831f206
    Distribution End Date
    2017-11-30

    Device Description

    CONN PROBE CB4627 BIOACT FLOW PEDIATRIC

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DPT PROBE, BLOOD-FLOW, EXTRAVASCULAR

    GMDN Terms

    Code Name
    31657 Blood flowmeter transducer, non-indwelling

    Identifiers

    Type ID
    Package 20673978563330
    Primary 00673978563336

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K830858 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – 40 Degrees Celsius