| Primary Device ID | 05060526070005 |
| NIH Device Record Key | 6e39faa0-9eb7-41c3-8b0b-6f6f252a64d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hayek RTX |
| Version Model Number | 01 |
| Company DUNS | 211319456 |
| Company Name | UNITED HAYEK INDUSTRIES (MANUFACTURING) LIMITED |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 05060526070005 [Primary] |
| BYT | Ventilator, External Body, Negative Pressure, Adult (Cuirass) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-12-18 |
| 05060526070487 - Hayek Oscillator | 2023-11-30 The Hayek Oscillator is a non-invasive, biphasic, cuirass ventilator which works on the principle of applying pressure around th |
| 05060526070005 - Hayek RTX | 2018-07-06The United Hayek RTX Ventilator is a non-invasive, biphasic, cuirass ventilator which works on the principle of applying pressure around the body to c |
| 05060526070005 - Hayek RTX | 2018-07-06 The United Hayek RTX Ventilator is a non-invasive, biphasic, cuirass ventilator which works on the principle of applying pressur |