| Primary Device ID | 04710961934875 |
| NIH Device Record Key | 369f9537-cb1e-4678-8c5c-acc7c698da43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone C.W.V. Reservoir (Top Outlet) |
| Version Model Number | 2013-1640 |
| Company DUNS | 656763489 |
| Company Name | FORTUNE MEDICAL INSTRUMENT CORP. |
| Device Count | 5 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04710961934875 [Unit of Use] |
| GS1 | 14710961934872 [Primary] |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-08 |
| Device Publish Date | 2022-01-31 |
| 14711182608306 - Silicone T Drainage Set With Eyes | 2023-11-01 |
| 14711182608313 - Silicone T Drainage Set With Eyes | 2023-11-01 |
| 04711182608163 - Rystora Skin Protector-Spray | 2022-02-08 |
| 04710961934844 - Silicone C.W.V. Reservoir | 2022-02-08 |
| 04710961934851 - Silicone C.W.V. Reservoir | 2022-02-08 |
| 04710961934868 - Silicone C.W.V. Reservoir | 2022-02-08 |
| 04710961934875 - Silicone C.W.V. Reservoir (Top Outlet) | 2022-02-08 |
| 04710961934875 - Silicone C.W.V. Reservoir (Top Outlet) | 2022-02-08 |
| 04710961934882 - Silicone C.W.V. Reservoir | 2022-02-08 |