| Primary Device ID | 04710961932550 |
| NIH Device Record Key | 9d0405d2-1ff1-47c0-8fe4-bd43650495a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone 3-way Foley Balloon Catheter (Standard Ba |
| Version Model Number | 1830-0520 |
| Company DUNS | 656763489 |
| Company Name | FORTUNE MEDICAL INSTRUMENT CORP. |
| Device Count | 10 |
| 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 | false |
| OTC Over-The-Counter | false |