Identity
- Trade Name
- ReliOn FDA UDI
- Generic Name
- Home-use/point-of-care blood glucose monitoring system IVD FDA UDI
- Device Name
- ReliOn ALL-IN-ONE Compact Blood Glucose Testing System 50 Test Strips With Built-In Meter FDA UDI
- Model / Reference
- ReliOn ALL-IN-ONE Compact Blood Glucose Testing System FDA UDI
- Description
- ReliOn ALL-IN-ONE Compact Blood Glucose Testing System 50 Test Strips With Built-In Meter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00021292009274 FDA UDI
- 510(k) Number
- K051147 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Home-use/point-of-care blood glucose monitoring system IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Home-use/point-of-care blood glucose monitoring system IVD
ReliOn by Walmart Stores — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Home-use/point-of-care blood glucose monitoring system IVD.
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Cleared under the same submission
K051147 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 II | Pending data |
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Manufacturer
- Manufacturer
- Walmart Stores
Sources (1)
- FDA UDI e342a76f-d891-4b88-80b4-5d2467a4ff4d 36 fields · synced May 31, 2026