FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Pro Comfort Blood Glucose Monitor Kit
DI: 00198715270303
·
Model: BGM107
·
Care Living Diagnostics Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Pro Comfort Blood Glucose Monitor Kit
- Primary DI
- 00198715270303
- Version / Model
- BGM107
- Catalog Number
- 19871-5270-30
- Company Name
- Care Living Diagnostics Inc.
- Labeler DUNS
- 125354643
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-25
- Public Version
- 1
- Public Version Date
- 2025-03-05
- Public Version Status
- New
- Public Device Record Key
- 1c931e2d-1bff-499d-98ec-78a7c1ba5c76
- Distribution End Date
- 2025-02-25
Device Description
BLOOD GLUCOSE MONITOR KIT BGM107 Meter BGM107 100 x Test Strips Lancing Device 100 x Lancets CR2032 Carrying Bag Instruction For Use (Read before use) Quick Start Guide
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | Clinical Chemistry | 862.1345 | 2 |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62537 | Glucose monitoring system IVD, home-use | A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00198715270303 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052208 | 000 |