BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CVS Health

    DI: 00050428504666 · Model: OX200 · WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CVS Health
    Primary DI
    00050428504666
    Version / Model
    OX200
    Company Name
    WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
    Labeler DUNS
    062312574
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-16
    Public Version
    2
    Public Version Date
    2021-11-10
    Public Version Status
    Update
    Public Device Record Key
    cbbcd043-aef6-4f42-a578-304b0d394f3b

    Device Description

    Relaxation Coach Pulse Oximeter

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    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
    PGJ Oximeter, Wellness

    GMDN Terms

    Code Name
    45607 Pulse oximeter

    Identifiers

    Type ID
    Primary 00050428504666
    Package 10050428504663

    Storage Conditions

    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal
    Type
    Storage Environment Humidity
    Temperature Range
    – 93 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -13 – 158 Degrees Fahrenheit