| Primary Device ID | 07640140860862 |
| NIH Device Record Key | fa77c922-150c-4259-bdff-153ad45dcf49 |
| Commercial Distribution Discontinuation | 2024-11-08 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Monsoon III Laserjet 40 |
| Version Model Number | 253105 |
| Company DUNS | 481327922 |
| Company Name | Acutronic Medical Systems AG |
| 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 | true |
| Manufacturing Date | true |
| 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 |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640140860862 [Primary] |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-11-11 |
| Device Publish Date | 2023-01-20 |
| 07640140860749 - Monsoon III Laserjet 70 | 2024-11-11 Laserjet 70, double lumen jet catheter acc. Biro, 70 cm length |
| 07640140860862 - Monsoon III Laserjet 40 | 2024-11-11Laserjet 40, Double lumen jet catheter acc. Biro, 40 cm length |
| 07640140860862 - Monsoon III Laserjet 40 | 2024-11-11 Laserjet 40, Double lumen jet catheter acc. Biro, 40 cm length |
| 07640140861395 - Monsoon III | 2024-11-11 + Universal Jet Ventilator USA |
| 07640140861616 - MONSOON+ | 2019-11-06 High frequency ventilator |