| Primary Device ID | 00841962120388 |
| NIH Device Record Key | 2df2b709-b1a8-4153-a581-6f19060a8e6b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lumen AirShuttle |
| Version Model Number | XT-5100-80 |
| Catalog Number | XT-5100-80 |
| Company DUNS | 808875397 |
| Company Name | Qfix |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 |
| Phone | +1 712-737-8688 |
| regulatory@cqmedical.com | |
| Phone | +1 712-737-8688 |
| regulatory@cqmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841962120388 [Primary] |
| FRZ | Device, Patient Transfer, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-10 |
| Device Publish Date | 2025-12-02 |
| 00841962120388 - Lumen AirShuttle | 2025-12-10Lumen AirShuttle |
| 00841962120388 - Lumen AirShuttle | 2025-12-10 Lumen AirShuttle |
| 00841962120395 - Symphony Locating Bar, PH Style | 2025-12-10 Symphony Locating Bar, PH Style |
| 00841962120401 - Portrait Head Only Mask Adapter for Access Supine | 2025-12-10 Portrait Head Only Mask Adapter for Access Supine |
| 00841962120418 - Portrait Head & Neck Mask Adapter for Access Supine | 2025-12-10 Portrait Head & Neck Mask Adapter for Access Supine |
| 10841962119464 - Symphony Locating Bar, PH Style | 2025-12-03 Symphony Locating Bar, PH Style |
| 00841962119856 - IntegraBite | 2025-11-21 IntegraBite Plates |
| 00841962120340 - Edge Guide System | 2025-09-19 Lithotomy Edge Guide System |
| 00841962119467 - Alpine Stirrups | 2025-07-17 Stirrup, Left |