BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    RENASYS

    DI: 05000223499150 · Model: 66803112 · SMITH & NEPHEW MEDICAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    RENASYS
    Primary DI
    05000223499150
    Version / Model
    66803112
    Catalog Number
    66803112
    Company Name
    SMITH & NEPHEW MEDICAL LIMITED
    Labeler DUNS
    216344051
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-07-02
    Public Version
    1
    Public Version Date
    2025-07-10
    Public Version Status
    New
    Public Device Record Key
    35ead54e-bbc4-40cc-803d-1fd984b1429a

    Device Description

    RENASYS Gauze Medium Wound Dressing Kit with AIRLOCK Technology and Soft Port

    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
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OMP negative pressure wound therapy Powered suction pump

    GMDN Terms

    Code Name
    34059 Wound dressing kit, medicated

    Identifiers

    Type ID
    Package 05000223499341
    Primary 05000223499150

    Customer Contacts

    Phone
    +1(800)238-7538
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify MEDIUM: MEDIUM

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from sunlight: -
    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep dry: -
    Type
    Special Storage Condition, Specify
    Special Conditions
    Lower limit of temperature: -
    Type
    Special Storage Condition, Specify
    Special Conditions
    Upper limit of temperature: -