FDA UDI
In Commercial Distribution
🇺🇸 United States
metene
DI: 10810011730356
·
Model: IC,30G
·
Tianjin Huahong Technology Co., Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
310
Basic Information
- Brand Name
- metene
- Primary DI
- 10810011730356
- Version / Model
- IC,30G
- Company Name
- Tianjin Huahong Technology Co., Ltd.
- Labeler DUNS
- 421272490
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 310
- Record Status
- Published
- Publish Date
- 2023-04-28
- Public Version
- 1
- Public Version Date
- 2023-05-08
- Public Version Status
- New
- Public Device Record Key
- 01deedf3-04b7-4248-a43f-e8cd78bde688
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | General, Plastic Surgery | 878.4850 | 2 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | General, Plastic Surgery | 878.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45142 | Blood lancing device tip | A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20810011730353 | GS1 | case | 27900 | In Commercial Distribution | |
| Primary | 10810011730356 | GS1 | ||||
| Unit of Use | 00810011730359 | GS1 |