DreamStation INX1025H19

GUDID 00606959065758

DreamStation BiPAP S/T25, No Bluetooth, India

Respironics, Inc.

Portable electric ventilator

• Primary Device ID: 00606959065758
• NIH Device Record Key: ee02b75a-9559-4639-b9ab-dc29542063e6
• Commercial Distribution Discontinuation: 2021-02-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DreamStation
• Version Model Number: DreamStation BiPAP S/T25, No Bluetooth, IN
• Catalog Number: INX1025H19
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959065758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092818

FDA Product Code

• MNS: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2025-08-11
• Device Publish Date: 2017-01-30

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