Identity
- Trade Name
- ReliOn™ Premier Voice Basic Meter FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- The ReliOn Premier Voice Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. FDA UDI
- Model / Reference
- 780001 FDA UDI
- Description
- The ReliOn Premier Voice Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00681131169851 FDA UDI
- 510(k) Number
- K121133 FDA UDI
- FDA Product Code
- JJX FDA UDICGA FDA UDINBW 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
- 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
Category: Glucose monitoring system IVD, home-use
ReliOn™ Premier Voice Basic Meter by Walmart Stores — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121133 also covers:
- ReliOn™ Premier Blood Glucose Test Strips — Walmart Stores
- ReliOn™ Premier Blood Glucose Test Strips — Walmart Stores
- ReliOn™ Premier Blood Glucose Test Strips — Walmart Stores
- ReliOn™ Premier Blood Glucose Test Strips — Walmart Stores
- ReliOn™ Premier Classic Meter — Walmart Stores
- ReliOn™ Premier Classic Meter — Walmart Stores
- ReliOn™ Premier Voice Basic Meter — Walmart Stores
- CareSens N Voice — i-SENS, Inc.
- VeraSens Voice — i-SENS, Inc.
- VeraSens Voice — i-SENS, Inc.
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
- Walmart Stores
Sources (1)
- FDA UDI 0acbfeb8-9287-4f76-9af6-a27faea6206e 36 fields · synced Jun 8, 2026