| Primary Device ID | 00365702488106 |
| NIH Device Record Key | 645775ee-21fb-4ee4-a68d-7904e9254f83 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACCU-CHEK SMART VIEW |
| Version Model Number | 06334032001 |
| Catalog Number | 06334032001 |
| 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 | 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 | 00365702488106 [Primary] |
| GS1 | 10365702488103 [Package] Package: [6 Units] In Commercial Distribution |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| 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 |
| 00365702514102 | ACCU-CHEK SMART VIEW CONTROL 2 |
| 10365702495101 | ACCU-CHEK SMART VIEW MAIL ORDER STRIP 36 |
| 00365702494107 | ACCU-CHEK SMART VIEW MED BEN STRIP 36/CS |
| 10365702493107 | ACCU-CHEK SMART VIEW 100CT STRIP 24/CS |
| 00365702492103 | ACCU-CHEK SMART VIEW 50CT STRIP 36/CS |
| 00365702488106 | ACCU-CHEK SMART VIEW CONTROL 6/CS |
| 00365702487109 | ACCU-CHEK SMART VIEW 10CT STRIP |