DreamStation AHX400S11
GUDID 00606959022430
DreamStation CPAP Pro, American Home Patient
Respironics, Inc.
Home CPAP unit| Primary Device ID | 00606959022430 |
| NIH Device Record Key | 81a7df0c-4490-4ca0-9322-33cb7516ab1a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DreamStation |
| Version Model Number | 00 |
| Catalog Number | AHX400S11 |
| Company DUNS | 080728314 |
| Company Name | Respironics, Inc. |
| 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 | false |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959022430 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131982
FDA Product Code
| BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-21 |
On-Brand Devices [DreamStation]
| 00606959022942 | DreamStation Cellular Modem, US with Oximetry |
| 00606959022928 | DreamStation WiFi Accessory, EU |
| 00606959022911 | DreamStation WiFi Accessory, EU, with PRI Label |
| 00606959022904 | DreamStation WiFi Accessory, Canada |
| 00606959022898 | DreamStation WiFi Accessory, US |
| 00606959022881 | DreamStation Cellular Modem, Japan |
| 00606959022874 | DreamStation Cellular Modem with Oximetry, Europe |
| 00606959022867 | DreamStation Cellular Modem with Oximetry, Europe, with PRI Label, Rental |
| 00606959022850 | DreamStation Cellular Modem, Canada |
| 00606959022652 | DreamStation Humidifier, Core Pack, Domestic |
| 00606959022645 | DreamStation Humidifier, Domestic |
| 00606959022638 | DreamStation Auto BiPAP with Humidifier, American Home Patient |
| 00606959022621 | DreamStation Auto BiPAP with Heated Humidifier, American Home Patient |
| 00606959022614 | DreamStation Auto BiPAP, American Home Patient |
| 00606959022607 | DreamStation BiPAP Pro with Heated Humidifier, American Home Patient |
| 00606959022591 | DreamStation BiPAP Pro with Humidifier, American Home Patient |
| 00606959022584 | DreamStation BiPAP Pro, America Home Patient |
| 00606959022577 | DreamStation Auto CPAP with Heated Humidifier, American Home Patient |
| 00606959022560 | DreamStation Auto CPAP with Humidifier, American Home Patient |
| 00606959022553 | DreamStation Auto CPAP, American Home Patient |
| 00606959022546 | DreamStation Auto BiPAP with Humidifier, Heated Tube, Domestic |
| 00606959022539 | DreamStation Auto BiPAP with Humidifier, Domestic |
| 00606959022522 | DreamStation Auto BiPAP, Domestic |
| 00606959022515 | DreamStation BiPAP Pro with Humidifier, Heated Tube, Domestic |
| 00606959022508 | DreamStation BiPAP Pro with Humidifier, Domestic |
| 00606959022492 | DreamStation BiPAP Pro, Domestic |
| 00606959022485 | DreamStation Auto CPAP with Humidifier, Heated Tube, Domestic |
| 00606959022478 | DreamStation Auto CPAP with Humidifier, Domestic |
| 00606959022461 | DreamStation Auto CPAP, Domestic |
| 00606959022454 | DreamStation CPAP Pro with Heated Humidifier, American Home Patient |
| 00606959022447 | DreamStation CPAP Pro System with Humidifier, American Home Patient |
| 00606959022430 | DreamStation CPAP Pro, American Home Patient |
| 00606959022423 | DreamStation CPAP Pro with Humidifier, Heated Tube, Domestic |
| 00606959022416 | DreamStation CPAP Pro with Humidifier, Domestic |
| 00606959022409 | DreamStation CPAP Pro, Domestic |
| 00606959022393 | DreamStation CPAP with Heated Humidifier, American Home Patient |
| 00606959022386 | DreamStation CPAP with Humidifier, American Home Patient |
| 00606959022379 | DreamStation CPAP with Humidifier, Heated Tube, Domestic |
| 00606959022362 | DreamStation CPAP with Humidifier, Domestic |
| 00606959022331 | DreamStation 15mm Heated Tube |
| 00606959022188 | DreamStation CPAP, American Home Patient |
| 00606959054776 | DreamStation Auto CPAP System with Humidifier, Heated Tubing, and Cellular Modem, USA |
| 00606959054769 | DreamStation Auto CPAP System with Humidifier and Cellular Modem, USA |
| 00606959054653 | DreamStation AVAPS30, BRAZIL, No Bluetooth |
| 00606959054646 | DreamStation ST30, BRAZIL, No Bluetooth |
| 00606959053304 | DreamStation Auto CPAP with Auto-Trial, for Brazil |
| 00606959053298 | DreamStation CPAP Pro with CPAP Check, for Brazil |
| 00606959053281 | DreamStation CPAP Pro with CPAP Check, Humidifier, and Heated Tubing for China |
| 00606959053274 | DreamStation Auto CPAP with Auto-Trial, Humidifier, and Heated Tubing for China |
| 00606959053267 | DreamStation Auto CPAP with Auto-Trial and Humidifier, for China |
Trademark Results [DreamStation]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DREAMSTATION 79170804 4995378 Live/Registered |
Koninklijke Philips N.V. 2015-06-25 |
 DREAMSTATION 77607776 3855395 Dead/Cancelled |
CHOI, HYUN WHAN 2008-11-05 |
 DREAMSTATION 77020980 not registered Dead/Abandoned |
Choi, Hyun Whan 2006-10-13 |
 DREAMSTATION 75670425 2611133 Dead/Cancelled |
Logic 3 International Limited 1999-03-30 |
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