| Primary Device ID | 40616258021551 |
| NIH Device Record Key | c49b2618-074e-4b5a-8152-021c1bbdb21f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Display Control Unit Sheath |
| Version Model Number | AVA 500 DCOV |
| Catalog Number | AVA 500 DCOV |
| Company DUNS | 058716649 |
| Company Name | BAYER MEDICAL CARE 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)633-7231 |
| ricustomercomplaints@bayer.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00616258021553 [Primary] |
| GS1 | 40616258021551 [Package] Contains: 00616258021553 Package: [25 Units] In Commercial Distribution |
| DXT | Injector And Syringe, Angiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2019-10-25 |
| 00616258007557 | Avanta Single Use Display Control Unit Sheath (SHEATH, DISPLAY CONTROL UNIT, MC, LA) (60728583) |
| 10616258007189 | Avanta Single Use Display Control Unit Sheath (SHEATH, DISPLAY CONTROL UNIT,MC,JA) (84194875) |
| 00616258005355 | Avanta Single Use Display Control Unit Sheath (ANGIO - AVANTA, SHEATH, DCU, MC) (60729563) |
| 40616258010234 | Avanta Single Use Display Control Unit Sheath(SHEATH, DISPLAY CONTROL UNIT,MC,JA2)(85231472) |
| 40616258021551 | SHEATH,DISPLAY CONTROL UNIT,MC,WLD (86566737) |
| 40616258024866 | SHEATH,DISPLAY CONTROL UNIT,MC,CORE (87640515) |