| Primary Device ID | 04710961935018 |
| NIH Device Record Key | f36bbaef-727b-4cc0-ac13-63b91d494acc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone Flat Drain |
| Version Model Number | 2014-0131 |
| Company DUNS | 656763489 |
| Company Name | FORTUNE MEDICAL INSTRUMENT CORP. |
| 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 | 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 | 04710961935018 [Unit of Use] |
| GS1 | 14710961935015 [Primary] |
| GCD | Connector, Catheter |
| 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 |
| 04710961934950 | 2014-0051 |
| 04710961935186 | 2014-3102 |
| 04710961935162 | 2014-3072 |
| 04710961935148 | 2014-2102 |
| 04710961935131 | 2014-2101 |
| 04710961935124 | 2014-2072 |
| 04710961935117 | 2014-2071 |
| 04710961935025 | 2014-0132 |
| 04710961935018 | 2014-0131 |
| 04710961935001 | 2014-0102 |
| 04710961934998 | 2014-0101 |
| 04710961934981 | 2014-0072 |
| 04710961934974 | 2014-0071 |
| 04710961934967 | 2014-0052 |