| Primary Device ID | 15404013000255 |
| NIH Device Record Key | 51d1cd28-8c2b-47f3-a778-1332224393b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hybernite RT |
| Version Model Number | Hybernite RT 15 ex |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05404013000258 [Primary] |
| GS1 | 15404013000255 [Package] Contains: 05404013000258 Package: [45 Units] In Commercial Distribution |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-27 |
| Device Publish Date | 2016-09-15 |
| 15404013000279 | Hybernite RT 19 ex |
| 15404013000262 | Hybernite RT 19 ins |
| 15404013000255 | Hybernite RT 15 ex |
| 15404013000248 | Hybernite RT 15 ins |
| 15404013000231 | Hybernite RT 12 ins+Inc |
| 15404013000224 | Hybernite RT 12 ex |
| 05404013000210 | Hybernite RT 12 ins |
| 15404013003737 | Hybernite RT 114 |
| 05404013003693 | Hybernite RT 114 Convenience kit |