BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Puritan Bennett

    DI: 20884521135076 · Model: Y-103075-00A · Covidien LP
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Puritan Bennett
    Primary DI
    20884521135076
    Version / Model
    Y-103075-00A
    Catalog Number
    Y-103075-00A
    Company Name
    Covidien LP
    Labeler DUNS
    058614483
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    7
    Public Version Date
    2023-02-13
    Public Version Status
    Update
    Public Device Record Key
    591cc0ad-40ec-4b32-8766-2a3c75b9c66c
    Distribution End Date
    2019-10-02

    Device Description

    Nasal Mask CPAP Interface,Shallow Cushion

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    BZD VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

    GMDN Terms

    Code Name
    35176 Anaesthesia face mask, reusable

    Identifiers

    Type ID
    Package 10884521135079
    Primary 20884521135076

    Customer Contacts

    Phone
    +1(508)261-8000
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K002001 000