BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GENTEC®

    DI: 06970966662632 · Model: 882EV-70-R · GENTEC(SHANGHAI)CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GENTEC®
    Primary DI
    06970966662632
    Version / Model
    882EV-70-R
    Company Name
    GENTEC(SHANGHAI)CORPORATION
    Labeler DUNS
    545287658
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-27
    Public Version
    2
    Public Version Date
    2020-05-13
    Public Version Status
    Update
    Public Device Record Key
    e74fa3a2-4bb8-4f9b-88d8-61372c400dcc

    Device Description

    882EV series suction regulator is a continuous subglottic suction regulator .It can be used for medical suction and enables the clinician to control the level of negative pressure for the operation of pharyngeal aspiration, tracheal suctioning etc.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    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
    KDP Regulator, Vacuum

    GMDN Terms

    Code Name
    37782 Vacuum suction regulator/regulation set, thoracic

    Identifiers

    Type ID
    Primary 06970966662632