BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    X-ray Flat Panel Detector

    DI: 06970597830745 · Model: CareView 1800Cwe · CareRay Digital Medical Technology Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    X-ray Flat Panel Detector
    Primary DI
    06970597830745
    Version / Model
    CareView 1800Cwe
    Company Name
    CareRay Digital Medical Technology Co., Ltd.
    Labeler DUNS
    421333508
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-14
    Public Version
    1
    Public Version Date
    2020-08-24
    Public Version Status
    New
    Public Device Record Key
    760961fa-20f4-4d43-8e93-2b912972a5f8

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

    GMDN Terms

    Code Name
    37643 Portable basic diagnostic x-ray system, digital

    Identifiers

    Type ID
    Primary 06970597830745

    Premarket Submissions

    Submission Number Supplement Number
    K201932 000