| Primary Device ID | 16935784420250 |
| NIH Device Record Key | 1284fc52-bb36-46cc-b39d-dbd5c3ed38e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioHermes GluCoA1c Blood Glucose and Glycohemoglobin Analyzer |
| Version Model Number | GLU-A1C M14 |
| Catalog Number | GCA-M31 |
| Company DUNS | 528192913 |
| Company Name | Wuxi Biohermes Bio & Medical Technology Co.,Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06935784420253 [Primary] |
| GS1 | 16935784420250 [Package] Contains: 06935784420253 Package: box [18 Units] In Commercial Distribution |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-05 |
| Device Publish Date | 2022-08-26 |
| 06935784420246 | GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use |
| 06935784420239 | GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use |
| 16935784420267 | GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use |
| 16935784420250 | GluCoA1c Blood Glucose and Glycohemoglobin Analyzer. Intended use: GluCoA1c analyzer is for use |