| Primary Device ID | 10365702700465 |
| NIH Device Record Key | 09c4c73b-7d5c-4e31-a01b-dff691965752 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Accu-Chek Safe-T-Pro |
| Version Model Number | 05888662160 |
| Catalog Number | 05888662160 |
| Company DUNS | 141608724 |
| Company Name | Roche Diagnostics Operations, Inc. |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | 00365702700468 [Primary] |
| GS1 | 10365702700465 [Package] Contains: 00365702700468 Package: [16 Units] In Commercial Distribution |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-27 |
| Device Publish Date | 2022-10-19 |
| 00365702702196 | Accu-Chek Safe-T-Pro Plus 5ct |
| 10365702702148 | Accu-Chek Safte-T-Pro Plus 200ct Coag 6/cs |
| 00365702700475 | Accu-Chek Safe-T-Pro Uno 10ct |
| 10365702700465 | Accu-Chek Safe-T-Pro Uno 200ct 16/cs |
| 10075537257897 | Accu-Chek Safe-T-Pro Plus 200ct |