BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mucolyse (10x100 mg)

    DI: 20628429001008 · Model: PL.701 · PRO-LAB, INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mucolyse (10x100 mg)
    Primary DI
    20628429001008
    Version / Model
    PL.701
    Catalog Number
    PL.701
    Company Name
    PRO-LAB, INCORPORATED
    Labeler DUNS
    960418395
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-25
    Public Version
    1
    Public Version Date
    2023-01-02
    Public Version Status
    New
    Public Device Record Key
    274e35b1-c002-47d3-a2ab-79dbe5de8c03

    Device Description

    Mucolyse presents an effective sputum digestant supplied in a simple, convenient, economical and safe format. Each vial, containing lyophilised predetermined quantities of Dithiothreitol and Phosphate Buffer, reconstitutes with 10 ml of sterile water, and then dilutes to 100 ml of active digestant solution.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JSK Supplement, Culture Media

    GMDN Terms

    Code Name
    42624 Sputum liquefaction/decontamination reagent IVD

    Identifiers

    Type ID
    Primary 20628429001008