| Primary Device ID | 10365702220109 |
| NIH Device Record Key | eef8e8c5-2201-4ab3-86bf-877036f4b50c |
| Commercial Distribution Discontinuation | 2018-07-03 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ACCU-CHEK COMPACT PLUS |
| Version Model Number | 05177294001 |
| 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 | true |
| 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 | 00365702220102 [Primary] |
| GS1 | 10365702220109 [Package] Contains: 00365702220102 Package: [8 Units] Discontinued: 2018-07-03 Not in Commercial Distribution |
| NBW | System, Test, Blood Glucose, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-04-29 |
| Device Publish Date | 2016-08-26 |
| 00365702701236 | Accu-Chek Compact Plus Control L2 (Bio) The UDI information was not placed on the vial label due |
| 10365702220109 | ACCU-CHEK COMPACT PLUS DME KIT |
| 10365702192109 | ACCU-CHEK COMPACT PLUS SAMPLE KIT 16/CS |
| 10075537490706 | ACCU-CHEK COMPACT PLUS CARE KIT 8/CASE |