FDA UDI
In Commercial Distribution
🇺🇸 United States
Uric Acid Test Strip
DI: 06935740727037
·
Model: URIT U10,10strips/vial
·
Urit Medical Electronic Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Uric Acid Test Strip
- Primary DI
- 06935740727037
- Version / Model
- URIT U10,10strips/vial
- Company Name
- Urit Medical Electronic Co., Ltd.
- Labeler DUNS
- 653742429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- 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
- b6e6e130-c482-4955-931e-0a587edd40e9
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 |
|---|---|---|---|---|
| JHC | Acid, Uric, Uricase (Oxygen Rate) | Clinical Chemistry | 862.1775 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62221 | Uric acid 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 disposable materials intended to be used for the quantitative measurement of uric acid 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. It is used to monitor the effectiveness of uric acid control in various disorders (e.g., renal failure, gout, leukaemia), and in patients receiving cytotoxic chemotherapy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06935740727037 | GS1 | ||||
| Unit of Use | 86935740727033 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius