FDA UDI
In Commercial Distribution
🇺🇸 United States
BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer
DI: 06935784410001
·
Model: A1C EZ 2.0
·
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer
- Primary DI
- 06935784410001
- Version / Model
- A1C EZ 2.0
- Catalog Number
- A1C-M21
- Company Name
- Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
- Labeler DUNS
- 528192913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-26
- Public Version
- 1
- Public Version Date
- 2022-09-05
- Public Version Status
- New
- Public Device Record Key
- 385eba8a-9931-4e4b-948a-b24d2da24e1a
Device Description
A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentration as anaid to monitor the risk of developing diabetes and control the status of diabetes.The HbA1c analyzer is specifically designed to be used with the corresponding test strip.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62206 | Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care | A collection of devices including a portable, electrically-powered, semi-automated or automated instrument (meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen. The measurement is typically based on an immunological method (e.g., immunoassay) and/or spectrophotometry, and is used to evaluate the long-term control of blood glucose concentration, primarily in persons with diabetes mellitus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16935784410008 | GS1 | box | 24 | In Commercial Distribution | |
| Primary | 06935784410001 | GS1 |