| Primary Device ID | 40616258010081 |
| NIH Device Record Key | e5a09304-98f2-418d-a139-29dda2edc928 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 200mL Sterile Disposable Qwik-Fit Syringe |
| Version Model Number | 200-FLS |
| Catalog Number | 200-FLS |
| 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 | 00616258010083 [Primary] |
| GS1 | 40616258010081 [Package] Contains: 00616258010083 Package: [50 Units] In Commercial Distribution |
| DXT | Injector And Syringe, Angiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-28 |
| Device Publish Date | 2019-05-20 |
| 10616258007233 | "Envision, Vistron, MCT- 200 ml syringe (ASSY,PKG,SYRINGE, 200ML, ODYSSEY,MC,JA) (84197076)" |
| 00616258005508 | Envision, Vistron, MCT- 200 ml syringe (CT - 200ML ENV/VIST SYRINGE KIT) (60728621) |
| 40616258010081 | Envision, Vistron, MCT- 200 ml syringe (ASSY,PKG,SYRINGE, 200ML, ODYSSEY,MC,JA2) (85232851) |