| Primary Device ID | H862TCY22 |
| NIH Device Record Key | 413d000b-1ec8-4e3d-bfff-1d331aa9b5a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tru-Close Suction Drainage System |
| Version Model Number | TCY2 |
| Catalog Number | TCY2 |
| Company DUNS | 192559557 |
| Company Name | URESIL, LLC |
| Device Count | 1 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H862TCY20 [Primary] |
| HIBCC | H862TCY21 [Package] Contains: H862TCY20 Package: DISPENSER [5 Units] In Commercial Distribution |
| HIBCC | H862TCY22 [Package] Contains: H862TCY21 Package: SHIPPER [5 Units] In Commercial Distribution |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-09-11 |
| H862TCY22 | "Y" Connector Tubing Set |
| H862TCS500DS2 | Tru-Close Suction Drainage System - 500ml - "D" port small |
| H862TCS500D2 | Tru-Close Suction Drainage System - 500ml - "D" port |
| H862TCS5002 | Tru-Close Suction Drainage System - 500ml |
| H862TCS300D2 | Tru-Close Suction Drainage System - 300ml - "D" port |
| H862TCS10002 | Tru-Close Suction Drainage System - 1000ml |
| 10817640020612 | Tru-Close Suction Drainage System - 500ml - "D" port small |
| 10817640020605 | Tru-Close Suction Drainage System - 500ml - "D" port |
| 10817640020599 | Tru-Close Suction Drainage System - 500ml |
| 10817640020582 | Tru-Close Suction Drainage System - 300ml - "D" port |
| 10817640020575 | Tru-Close Suction Drainage System - 1000ml |
| 10817640020629 | "Y" Connector Tubing Set |
| 00817640021742 | Tru-Close Suction Drainage System - 500ml - "D" port small |
| 00817640021735 | Tru-Close Suction Drainage System - 500ml - "D" port |
| 00817640021728 | Tru-Close Suction Drainage System - 500ml |
| 00817640021711 | Tru-Close Suction Drainage System - 300ml - "D" port |
| 00817640021704 | Tru-Close Suction Drainage System - 1000ml |