FDA UDI
In Commercial Distribution
🇺🇸 United States
Gochek2
DI: 06958590303046
·
Model: 1026
·
Microtech Medical (Hangzhou) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Gochek2
- Primary DI
- 06958590303046
- Version / Model
- 1026
- Company Name
- Microtech Medical (Hangzhou) Co., Ltd.
- Labeler DUNS
- 542987562
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2021-11-12
- Public Version
- 1
- Public Version Date
- 2021-11-22
- Public Version Status
- New
- Public Device Record Key
- dd7300e6-3cd9-4547-8d6d-64e150ad9ca2
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 |
|---|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53307 | Glucose 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 for the quantitative measurement of glucose in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06958590303046 | GS1 | ||||
| Unit of Use | 06958590303329 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193340 | 000 |