| Primary Device ID | 10365702702827 |
| NIH Device Record Key | 7b10ca07-feee-4a03-894c-5e84e3e507d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Accu-Chek Softclix |
| Version Model Number | 09917764001 |
| Catalog Number | 09917764001 |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | 00365702702820 [Primary] |
| GS1 | 10365702702827 [Package] Contains: 00365702702820 Package: [12 Units] In Commercial Distribution |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-30 |
| Device Publish Date | 2023-03-22 |
| 04015630084937 | Accu-Chek Softclix Lancets 10/pk |
| 04015630082209 | Accu-Chek Softclix Black Bulk 100 |
| 00365702897106 | Accu-Chek Softclix Mailorder 100ct 12/cs |
| 00365702700123 | Accu-Chek Softclix AST Kit USA |
| 00365702400108 | Accu-Chek Softclix (black) USA 12/case |
| 00365702156104 | Accu-Chek Softclix HN Lancets 100ct 12cs |
| 00075537009710 | Accu-Chek Softclix Lancets 100ct 12/cs |
| 10365702702827 | Accu-Chek Softclix Kit Canada |