BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Dexcom CLARITY

    DI: B059CLARITY35000011 · Model: 350-0011 · SWEETSPOT DIABETES CARE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dexcom CLARITY
    Primary DI
    B059CLARITY35000011
    Version / Model
    350-0011
    Catalog Number
    350-0011
    Company Name
    SWEETSPOT DIABETES CARE, INC.
    Labeler DUNS
    963889204
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-26
    Public Version
    4
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    314065cc-95ee-4485-b777-299fc28199cc
    Distribution End Date
    2016-12-19

    Device Description

    Dexcom CLARITY software, web-based data management product is intended for use by both patients and healthcare professionals to assist people with diabetes in the review, analysis and evaluation of historical CGM data to support effective diabetes management. It is intended for use as an accessory to CGM devices with data interface capabilities. With RCP, it provides additional administrative features for use by Clinicians to access Dexcom CLARITY reports (digital or print) for their patients with diabetes. These features do not change the intended use of CLARITY. They improve the usefulness of it from the clinician perspective.

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PHV Continuous Glucose Monitor Retrospective Data Analysis Software

    GMDN Terms

    Code Name
    59231 Noninvasive interstitial-fluid glucose monitoring device

    Identifiers

    Type ID
    Primary B059CLARITY35000011