FDA UDI
In Commercial Distribution
🇺🇸 United States
ForaCare
DI: 00816042013881
·
Model: GD20
·
FORA CARE INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- ForaCare
- Primary DI
- 00816042013881
- Version / Model
- GD20
- Company Name
- FORA CARE INC.
- Labeler DUNS
- 004340807
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2020-04-06
- Public Version
- 1
- Public Version Date
- 2020-04-14
- Public Version Status
- New
- Public Device Record Key
- dd5fdc0c-aa4e-4c4f-8af7-58adf3b3d013
Device Description
Blood Glucose Test Strips
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| LFR | Glucose Dehydrogenase, Glucose | 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 | 80816042013887 | GS1 | ||||
| Primary | 00816042013881 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101631 | 000 |