BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    HAEMONETICS ORTHOPAT ADVANCE SYSTEM

    DI: 30812747017910 · Model: OPA-E-US · HAEMONETICS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HAEMONETICS ORTHOPAT ADVANCE SYSTEM
    Primary DI
    30812747017910
    Version / Model
    OPA-E-US
    Company Name
    HAEMONETICS CORPORATION
    Labeler DUNS
    057827420
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-24
    Public Version
    5
    Public Version Date
    2023-10-19
    Public Version Status
    Update
    Public Device Record Key
    8e661747-acd0-43cb-8aa7-45b9325c74da
    Distribution End Date
    2023-09-29

    Device Description

    ORTHOPAT ADVANCE, LN OPA-E-US

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CAC Apparatus, Autotransfusion

    GMDN Terms

    Code Name
    66789 Autotransfusion system blood collection/processing pump

    Identifiers

    Type ID
    Primary 30812747017910

    Customer Contacts

    Phone
    +1(800)-537-2802
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K122262 000