| Primary Device ID | 00365702134102 |
| NIH Device Record Key | 19208562-8420-4c94-a19b-04264a5c9e91 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACCU-CHEK AVIVA PLUS |
| Version Model Number | 07021941001 |
| Catalog Number | 07021941001 |
| 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 | 00365702134102 [Primary] |
| GS1 | 10365702134109 [Package] Package: [8 Units] 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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-26 |
| 00365702700932 | VIAL LBLD 10CT STRIP AC AVIVA PLUS BRK |
| 00365702445109 | ACCU-CHEK AVIVA PLUS SAMPLE KIT 16/CASE |
| 10365702438108 | ACCU-CHEK AVIVA PLUS 50 HN STP BRK 36/CS |
| 00365702437104 | ACCU-CHEK AVIVA PLUS 50 MED-BEN BRK 36/C |
| 10365702436104 | ACCU-CHEK AVIVA PLUS 50 MLRDR BRK 36/CS |
| 10365702408101 | ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C |
| 10365702407104 | ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C |
| 00365702405103 | ACCU-CHEK AVIVA PLUS 10CT STRIP BRK |
| 00365702134102 | ACCU-CHEK AVIVA PLUS HNP KIT 8/CASE |
| 00365702102101 | ACCU-CHEK AVIVA PLUS METER-ONLY |
| 00365702101104 | ACCU-CHEK AVIVA PLUS RETAIL KIT 8/CASE |