Identity
- Trade Name
- TRUE FOCUS FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- Walgreens TRUE FOCUS Self Monitoring Blood Glucose Meter box FDA UDI
- Model / Reference
- TRUE FOCUS Self Monitoring Blood Glucose Meter FDA UDI
- Description
- Walgreens TRUE FOCUS Self Monitoring Blood Glucose Meter box FDA UDI
Identifiers
- Catalog Number
- UE4001-00 FDA UDI
- Primary DI / UDI-DI
- 00311917188065 FDA UDI
- 510(k) Number
- K131013 FDA UDI
- FDA Product Code
- JJX FDA UDINBW FDA UDILFR FDA UDI
- GMDN Term
- Glucose monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI862.1345 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
True Focus by Trividia Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K131013 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Trividia Health, Inc.
Sources (1)
- FDA UDI 4de9114c-3c1f-460b-9bb4-56019aa89b43 38 fields · synced Jun 8, 2026