FDA UDI
In Commercial Distribution
🇺🇸 United States
Blood Lipid Test Strip
DI: 06935740726986
·
Model: PFS 30,10strips/vial×2/box
·
Urit Medical Electronic Co., Ltd.
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Blood Lipid Test Strip
- Primary DI
- 06935740726986
- Version / Model
- PFS 30,10strips/vial×2/box
- Company Name
- Urit Medical Electronic Co., Ltd.
- Labeler DUNS
- 653742429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2024-07-12
- Public Version
- 1
- Public Version Date
- 2024-07-22
- Public Version Status
- New
- Public Device Record Key
- ded875ff-63e4-416b-91b2-59fc0ae550fe
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | Clinical Chemistry | 862.1175 | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | Clinical Chemistry | 862.1475 | 1 |
| JGY | Colorimetric Method, Triglycerides | Clinical Chemistry | 862.1705 | 1 |
| MRR | System, Test, Low Density, Lipoprotein | Clinical Chemistry | 862.1475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62643 | Multiple clinical chemistry analyte monitoring system IVD, home-use | A collection of devices including a portable, electrically-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 together for the quantitative measurement of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. It is intended 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06935740726986 | GS1 | ||||
| Unit of Use | 86935740726982 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius