FDA UDI
In Commercial Distribution
🇺🇸 United States
Blood Ketone Test Strips
DI: 16971404131199
·
Model: SM311
·
e-Linkcare Meditech Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
8
Pkg Device Count
15
Basic Information
- Brand Name
- Blood Ketone Test Strips
- Primary DI
- 16971404131199
- Version / Model
- SM311
- Company Name
- e-Linkcare Meditech Co., Ltd
- Labeler DUNS
- 540481217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 15
- Record Status
- Published
- Publish Date
- 2021-12-17
- Public Version
- 2
- Public Version Date
- 2021-12-31
- Public Version Status
- Update
- Public Device Record Key
- c75f1d8b-cb44-485e-a1fc-7c2e95feac66
Device Description
Blood ketone Monitoring Meter with Blood Ketone Test Strips are intended for use for the quantitative measurement of B -hydroxybutyrate (B -ketone) in fresh capillary whole blood or venous whole blood.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Clinical Chemistry | 862.1435 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52853 | Glucose/ketone/lipid profile IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26971404131196 | GS1 | Box | 15 | In Commercial Distribution | |
| Primary | 16971404131199 | GS1 | ||||
| Package | 26971404130939 | GS1 | Box | 30 | In Commercial Distribution | |
| Package | 36971404131193 | GS1 | carton | 100 | Not in Commercial Distribution | 2021-12-30 |
| Package | 36971404130936 | GS1 | Carton | 160 | Not in Commercial Distribution | 2021-12-30 |
| Unit of Use | 06971404131192 | GS1 | ||||
| Package | 36971404130004 | GS1 | carton | 100 | In Commercial Distribution | |
| Package | 36971404130011 | GS1 | carton | 160 | In Commercial Distribution |