| Primary Device ID | 03610230007624 |
| NIH Device Record Key | bde9e137-518b-4189-a0b9-ab605905b5c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Yumizen C1200 CO2 Cal |
| Version Model Number | 1300023921 |
| Company DUNS | 273647420 |
| Company Name | HORIBA ABX SAS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| 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 | 03610230007624 [Primary] |
| JIT | Calibrator, Secondary |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-22 |
| Device Publish Date | 2020-09-14 |
| 03610230005545 - ABX PENTRA CK CONTROL | 2024-07-18 |
| 03610230005392 - ABX PENTRA HBA1C WB | 2024-07-16 |
| 03610230005408 - ABX PENTRA HBA1C WB CAL | 2024-07-16 |
| 03610230005415 - ABX PENTRA HBA1C WB CONTROL | 2024-07-16 |
| 03610230005460 - ABX PENTRA HBA1C WB HEMOLYSIS REAGENT | 2024-07-16 |
| 03610230008157 - NUCEDIFF (1L) | 2024-06-07 |
| 03610230008508 - Yumizen SPS | 2024-06-07 |
| 03610230008928 - Yumizen T6000 | 2024-06-07 Right module SPS only |