| Primary Device ID | 15404013002068 |
| NIH Device Record Key | d734efd4-b3be-47be-8050-bd0127ff39c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clasic Rt |
| Version Model Number | Classic RT 19 x 500 Blue |
| Company DUNS | 371165452 |
| Company Name | Plastiflex Group NV |
| Device Count | 1 |
| 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 | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05404013002061 [Primary] |
| GS1 | 15404013002068 [Package] Contains: 05404013002061 Package: [135 Units] In Commercial Distribution |
| GS1 | 25404013002065 [Package] Contains: 05404013002061 Package: [15 Units] In Commercial Distribution |
| BZO | Set, Tubing And Support, Ventilator (W Harness) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-27 |
| Device Publish Date | 2019-03-28 |
| 05404013000807 - Hybernite | 2022-07-11 |
| 05404013004553 - Hybernite | 2022-07-11 |
| 05404013004560 - Hybernite | 2022-07-11 |
| 05404013004577 - Hybernite | 2022-07-11 |
| 05404013003693 - Hybernite RT | 2020-08-17 Hybernite RT 114 Convenience kit |
| 15404013003737 - Hybernite RT | 2020-08-17 Hybernite RT 114 |
| 15404013000019 - Hybernite | 2019-12-11 |
| 15404013000095 - Hybernite | 2019-12-11 |