BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pip

    DI: 00732671009418 · Model: 941 · AMITY HOLDINGS, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pip
    Primary DI
    00732671009418
    Version / Model
    941
    Catalog Number
    941
    Company Name
    AMITY HOLDINGS, LLC
    Labeler DUNS
    016069284
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-21
    Public Version
    3
    Public Version Date
    2022-04-11
    Public Version Status
    Update
    Public Device Record Key
    213ad6d0-f9ff-4cd3-929b-ffb898491f2c
    Distribution End Date
    2026-05-13

    Device Description

    Blood Glucose Test Strips

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CGA Glucose Oxidase, Glucose
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    62537 Glucose monitoring system IVD, home-use

    Identifiers

    Type ID
    Primary 00732671009418
    Package 10732671109412
    Package 20732671209416
    Package 30732671309410

    Premarket Submissions

    Submission Number Supplement Number
    K113208 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    41 – 86 Degrees Fahrenheit