FDA UDI
In Commercial Distribution
🇺🇸 United States
CareLiving Blood Glucose Test Strips 100ct
DI: 00383568100819
·
Model: MM1100-100
·
Care Living Diagnostics Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- CareLiving Blood Glucose Test Strips 100ct
- Primary DI
- 00383568100819
- Version / Model
- MM1100-100
- Catalog Number
- 83568-1008-19
- Company Name
- Care Living Diagnostics Inc.
- Labeler DUNS
- 125354643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-11-15
- Public Version
- 1
- Public Version Date
- 2023-11-23
- Public Version Status
- New
- Public Device Record Key
- 29fe89da-6d9f-45d8-96f5-99d72db2283d
Device Description
Blood Glucose Test Strips,50ct/box,two box, for use with blood glucose monitoring system
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| 53303 | Glucose IVD, kit, electrometry | A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10383568100816 | GS1 | ||||
| Primary | 00383568100819 | GS1 |