BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    t:slim X2 Cartridge, t:lock, 2 Pack

    DI: 00853052007233 · Model: 1000728 · Tandem Diabetes Care, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

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    Basic Information

    Brand Name
    t:slim X2 Cartridge, t:lock, 2 Pack
    Primary DI
    00853052007233
    Version / Model
    1000728
    Company Name
    Tandem Diabetes Care, Inc.
    Labeler DUNS
    827900809
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2017-08-25
    Public Version
    4
    Public Version Date
    2023-05-04
    Public Version Status
    Update
    Public Device Record Key
    e8f8b9f7-d140-4b12-8858-3d593a8c578f

    Device Description

    t:slim G4 / X2 Cartridge, t:lock, 2 Pack

    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 Unsafe
    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
    OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

    GMDN Terms

    Code Name
    35838 Ambulatory insulin infusion pump reservoir

    Identifiers

    Type ID
    Primary 00853052007233
    Unit of Use 00853052007547

    Customer Contacts

    Phone
    877-801-6901
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P140015 000
    P140015 001
    P140015 002
    P140015 003
    P140015 004
    P140015 005
    P140015 013
    P140015 014
    P140015 017
    P140015 019

    Device Sizes

    Type Value Unit Text
    Total Volume 3 Milliliter

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -4 – 140 Degrees Fahrenheit
    Type
    Storage Environment Humidity
    Temperature Range
    20 – 90 Percent (%) Relative Humidity