| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00616784500720 [Unit of Use] |
| GS1 | 00616784500737 [Primary] |
| OHR | Catheter Care Tray |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2018-08-18 |
| 00810180840163 - DynaSafety Cotton-Tipped Applicators in Sealed Vial,3" | 2024-11-19 |
| 00840117341210 - Medicine Cups 1oz | 2024-11-05 |
| 00840117312906 - Resp-O2 Endotracheal Tube Cuffed, 4.0 mm | 2024-11-01 Sterile-EO |
| 00840117312920 - Resp-O2 Endotracheal Tube Cuffed, 4.5 mm | 2024-11-01 Sterile-EO |
| 00840117317475 - Resp-O2 Endotracheal Tube Cuffed, 5.0 mm | 2024-11-01 Sterile-EO |
| 00840117312968 - Resp-O2 Endotracheal Tube Cuffed, 5.5 mm | 2024-11-01 Sterile-Eo |
| 00840117312982 - Resp-O2 Endotracheal Tube Cuffed, 6.0 mm | 2024-11-01 Sterile-Eo |
| 00840117313002 - Resp-O2 Endotracheal Tube Cuffed, 6.5 mm | 2024-11-01 Sterile-Eo |