BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RenewTM NCP-5 External Counterpulsation System

    DI: 00865089000316 · Model: NCP-5 · S2 Equipment LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RenewTM NCP-5 External Counterpulsation System
    Primary DI
    00865089000316
    Version / Model
    NCP-5
    Company Name
    S2 Equipment LLC
    Labeler DUNS
    084717183
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-06-25
    Public Version
    1
    Public Version Date
    2018-07-26
    Public Version Status
    New
    Public Device Record Key
    9f2d3742-12f5-46fb-8257-91c26bb8eff9

    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
    Yes
    MRI Safety
    MR Unsafe
    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
    DRN Device, Counter-Pulsating, External

    GMDN Terms

    Code Name
    61283 External counterpulsation system, mobile

    Identifiers

    Type ID
    Primary 00865089000316

    Customer Contacts

    Phone
    248-987-7848
    Email
    [email protected]

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    -15 – 50 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    10 – 95 Percent (%) Relative Humidity
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    45 – 105 KiloPascal