| Primary Device ID | 00365702291102 |
| NIH Device Record Key | 67998aa5-3685-4f5a-90ba-7b1e84b0d95e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Accu-Chek Fastclix |
| Version Model Number | 05360188001 |
| Catalog Number | 05360188001 |
| 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 | 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 | 00365702291102 [Primary] |
| GS1 | 10365702291109 [Package] Package: [12 Units] In Commercial Distribution |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-05 |
| Device Publish Date | 2022-09-27 |
| 04015630083923 | Accu-Chek Fastclix 6 Lancet Drum Bulk 100 |
| 04015630065615 | Accu-Chek Fastclix Device Bulk 100 |
| 00365702702219 | Accu-Chek Fastclix AST Kit USA |
| 00365702481107 | Accu-Chek Fastclix MO/RP/AST Kit USA |
| 00365702291102 | Accu-Chek Fastclix 102 Lancets DME 12/cs |
| 00365702288102 | Accu-Chek Fastclix 102 Lancets Rtl 12/cs |
| 10365702702803 | Accu-Chek Fastclix Kit Canada |