Identity
- Trade Name
- CareLiving Blood Glucose Monitor Kit FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- BLOOD GLUCOSE MONITOR KIT CareLiving BGM101 Meter CareLiving BGM101 100 x Test Strips CareLiving Lancing Device CareLiving 100 x Lancets 2 x AAA Batteries 1 Control Solution Carrying Bag Instruction For Use (Read before use) Quick Start Guide FDA UDI
- Model / Reference
- BGM101 FDA UDI
- Description
- BLOOD GLUCOSE MONITOR KIT CareLiving BGM101 Meter CareLiving BGM101 100 x Test Strips CareLiving Lancing Device CareLiving 100 x Lancets 2 x AAA Batteries 1 Control Solution Carrying Bag Instruction For Use (Read before use) Quick Start Guide FDA UDI
Identifiers
- Catalog Number
- 83568-1008-02 FDA UDI
- Primary DI / UDI-DI
- 00383568100802 FDA UDI
- 510(k) Number
- K052208 FDA UDI
- FDA Product Code
- CGA FDA UDINBW 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
- 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
Yes
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
CareLiving Blood Glucose Monitor Kit by Care Living Diagnostics Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K052208 also covers:
- CareLiving BGM101 Blood Glucose Meter — CARE LIVING DIAGNOSTICS INC
- Easy Trak II Blood Glucose Meter — HOME AIDE DIAGNOSTICS, INC.
- Easy Trak II Control Solution High — HOME AIDE DIAGNOSTICS, INC.
- Easy Trak II Glucose Test Strips 25 count — HOME AIDE DIAGNOSTICS, INC.
- Glucose Pilot — SYNTRON BIORESEARCH, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Care Living Diagnostics Inc
Sources (1)
- FDA UDI eb7604a1-593a-4190-898e-d560fe437349 36 fields · synced May 30, 2026