| Primary Device ID | 04015630049950 |
| NIH Device Record Key | cb472276-fec5-41f1-bd87-90d11e5f6b21 |
| Commercial Distribution Discontinuation | 2021-09-08 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Accu-Chek Ultraflex |
| Version Model Number | 04626613001 |
| Catalog Number | 04626613001 |
| Company DUNS | 313212471 |
| Company Name | Roche Diabetes Care GmbH |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| 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 | 04015630049950 [Primary] |
| GS1 | 54015630049955 [Unit of Use] |
| FPA | Set, Administration, Intravascular |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[04015630049950]
Ethylene Oxide
[04015630049950]
Ethylene Oxide
[04015630049950]
Ethylene Oxide
[04015630049950]
Ethylene Oxide
[04015630049950]
Ethylene Oxide
[04015630049950]
Ethylene Oxide
[04015630049950]
Ethylene Oxide
[04015630049950]
Ethylene Oxide
[04015630049950]
Ethylene Oxide
[04015630049950]
Ethylene Oxide
[04015630049950]
Ethylene Oxide
[04015630049950]
Ethylene Oxide
[04015630049950]
Ethylene Oxide
[04015630049950]
Ethylene Oxide
[04015630049950]
Ethylene Oxide
[04015630049950]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-07-25 |
| Device Publish Date | 2016-08-25 |
| 04015630888658 | Accu-Chek Ultraflex pack of two 6/60 2pc |
| 04015630888610 | Accu-Chek Ultraflex I 6/30 10pcs |
| 04015630052431 | Accu-Chek Ultraflex pack of two 2pcs |
| 04015630888634 | Accu-Chek Ultraflex I 6/80 10pcs |
| 04015630888627 | Accu-Chek Ultraflex I 6/60 10pcs |
| 04015630049974 | Accu-Chek Ultraflex I 10/110 10pcs |
| 04015630049967 | Accu-Chek Ultraflex I 10/80 10pcs |
| 04015630049950 | Accu-Chek Ultraflex I 10/60 10pcs |
| 04015630049943 | Accu-Chek Ultraflex I 8/110 10pcs |
| 04015630049936 | Accu-Chek Ultraflex I 8/80 10pcs |
| 04015630049929 | Accu-Chek Ultraflex I 8/60 10pcs |