Identity
- Trade Name
- ReliOn Ultima FDA UDI
- Generic Name
- Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
- Device Name
- ReliOn Ultima Blood Glucose Test Strips FDA UDI
- Model / Reference
- 70122 FDA UDI
- Description
- ReliOn Ultima Blood Glucose Test Strips FDA UDI
Identifiers
- Catalog Number
- 70122 FDA UDI
- Primary DI / UDI-DI
- 00681131060318 FDA UDI
- 510(k) Number
- K083223 FDA UDI
- FDA Product Code
- LFR FDA UDINBW FDA UDIJJX FDA UDI
- GMDN Term
- Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI862.1660 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: Multiple clinical chemistry analyte monitoring system IVD, home-use
ReliOn Ultima by Walmart Stores — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple clinical chemistry analyte monitoring system IVD, home-use.
- FORA — FORA CARE INC. · Class II
- FORA — FORA CARE INC. · Class II
- STAT-Site WB Blood Glucose Test Strips — STANBIO LABORATORY, L.P. · Class II
- KetoSens — i-SENS, Inc. · Class I
- KetoSens — i-SENS, Inc. · Class I
- STAT-Site WB Blood Glucose Test Strips — STANBIO LABORATORY, L.P. · Class II
- FreeStyle Lite — ABBOTT DIABETES CARE INC · Class II
- Blood Ketone Control solution(level 3) — e-Linkcare Meditech Co., Ltd · Class I
Cleared under the same submission
K083223 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Walmart Stores
Sources (1)
- FDA UDI 665c76b5-5e16-4c81-abb2-cce9350e6c6c 37 fields · synced May 29, 2026