| Primary Device ID | 00616784500737 |
| NIH Device Record Key | beb4a48d-d250-4e8a-9a8a-49f58858bffd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Closed Circuit Foley Catheter Tray - Sterile - 18 FR |
| Version Model Number | 5007 |
| Company DUNS | 008124539 |
| Company Name | DYNAREX CORPORATION |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |