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ReliOn™ Premier Compact Blood Glucose Monitoring System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- ReliOn™ Premier Compact Blood Glucose Monitoring System FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- The ReliOn Premier Compact 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. Carton contains: ReliOn Premier Compact Meter DI# 00194346240913, ReliOn Premier Test Strips 50ct DI# 00194346219261, Lancing Device, Lancets and Literature. FDA UDI
- Model / Reference
- 783110 FDA UDI
- Description
- The ReliOn Premier Compact 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. Carton contains: ReliOn Premier Compact Meter DI# 00194346240913, ReliOn Premier Test Strips 50ct DI# 00194346219261, Lancing Device, Lancets and Literature. FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00194346240913 FDA UDI
- 510(k) Number
- K120759 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Glucose monitoring system IVD, home-use 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose monitoring system IVD, home-use
ReliOn™ Premier Compact Blood Glucose Monitoring System by Walmart Stores — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 d245978d-9ad1-439e-bd7e-5709f8f329e9 37 fields · synced Jun 1, 2026