FDA UDI
In Commercial Distribution
🇺🇸 United States
BLOOD GLUCOSE MONITORING SYSTEM (HanrayCare)
DI: 04897137180011
·
Model: TD-4125
·
Hongkong Uni-innovation Co., Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BLOOD GLUCOSE MONITORING SYSTEM (HanrayCare)
- Primary DI
- 04897137180011
- Version / Model
- TD-4125
- Company Name
- Hongkong Uni-innovation Co., Limited
- Labeler DUNS
- 989065642
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-23
- Public Version
- 1
- Public Version Date
- 2024-05-01
- Public Version Status
- New
- Public Device Record Key
- e7f2c648-41a5-4ef2-a25a-d489c0c88fa6
Device Description
Meter x1 Test Strip x100 Lancing Device x1 Sterile Lancet x100
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 62646 | Glucose analyser IVD, point-of-care | An electrically-powered instrument intended to be used exclusively at the point-of-care by medical professionals for the quantitative in vitro measurement of glucose levels in whole blood. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04897137180011 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K124040 | 000 |