BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PBS 1X Dulbecco's Phosphate Buffered Saline Solution

    DI: 00810195240385 · Model: 9235-500ML · IRVINE SCIENTIFIC, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PBS 1X Dulbecco's Phosphate Buffered Saline Solution
    Primary DI
    00810195240385
    Version / Model
    9235-500ML
    Catalog Number
    9235
    Company Name
    IRVINE SCIENTIFIC, LLC
    Labeler DUNS
    121584789
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-06-02
    Public Version
    1
    Public Version Date
    2025-06-10
    Public Version Status
    New
    Public Device Record Key
    773a73c8-9bb9-4f71-b940-bdb6216327a6

    Device Description

    PBS 1X Dulbecco's Phosphate Buffered Saline Solution. 500mL bottle.

    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
    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
    MQL Media, Reproductive

    GMDN Terms

    Code Name
    44046 IVF medium

    Identifiers

    Type ID
    Primary 00810195240385

    Premarket Submissions

    Submission Number Supplement Number
    K991342 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius