| Primary Device ID | 00365702508101 |
| NIH Device Record Key | d3e395d5-9927-48d1-942d-b32d3d59f025 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACCU-CHEK 360 |
| Version Model Number | 06604765001 |
| Catalog Number | 06604765001 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00365702508101 [Primary] |
| MRZ | Accessories, Pump, Infusion |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-26 |
| 00365702702417 - ACCU-CHEK GUIDE LINK | 2023-09-29 ACCU-CHEK GUIDE LINK MG/DL 118 |
| 10365702702889 - ACCU-CHEK GUIDE LINK | 2023-09-29 ACCU-CHEK GUIDE LINK SAMPLE mg/dl MO US |
| 10365702702476 - ACCU-CHEK GUIDE LINK | 2023-09-14 Accu-Chek Guide Link SC mg/dL |
| 10365702702537 - ACCU-CHEK GUIDE LINK | 2023-09-14 Accu-Chek Guide Link MO Replacement US |
| 10365702702803 - Accu-Chek Fastclix | 2023-03-30 Accu-Chek Fastclix Kit Canada |
| 10365702702827 - Accu-Chek Softclix | 2023-03-30 Accu-Chek Softclix Kit Canada |
| 00365702702684 - Instant White Label | 2022-10-31 IWL Lancets 10ct |
| 10075537257897 - Accu-Chek Safe-T-Pro | 2022-10-27 Accu-Chek Safe-T-Pro Plus 200ct |