DreamStation Go EUG400S15

GUDID 00606959048638

DreamStation Go with Bluetooth, Europe

Respironics, Inc.

Home CPAP unit

• Primary Device ID: 00606959048638
• NIH Device Record Key: 668c07e6-dcd6-4ee9-91df-2721b584e5a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamStation Go
• Version Model Number: CPAP BT
• Catalog Number: EUG400S15
• 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: 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

Customer Support Contacts

• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com
• Phone: +1(724)387-4000
• Email: Respironics.service@philips.com

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 -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 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959048638 [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: 2017-10-10

On-Brand Devices [DreamStation Go]

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• 00606959050242: DreamStation Go Auto with Bluetooth, Malaysia
• 00606959050235: DreamStation Go Auto with Bluetooth, Indonesia
• 00606959050228: DreamStation Go Auto with Bluetooth, Taiwan
• 00606959050211: DreamStation Go Auto with Bluetooth, Italy
• 00606959050204: DreamStation Go Auto with Bluetooth, Turkey
• 00606959050198: DreamStation Go Auto with Bluetooth, Saudi Arabia
• 00606959050006: DreamStation Go Auto with Bluetooth, India
• 00606959049994: DreamStation Go Auto with Bluetooth, Switzerland
• 00606959048669: DreamStation Go Auto CPAP System with Bluetooth, United Kingdom
• 00606959048652: DreamStation Go Auto with Bluetooth, Flaship Store, Europe
• 00606959048645: DreamStation Go Auto with Bluetooth, Europe
• 00606959048638: DreamStation Go with Bluetooth, Europe
• 00606959048607: DreamStation Go with Bluetooth, Canada
• 00606959048461: DreamStation Go Auto with Bluetooth, Benelux-Netherlands
• 00606959048454: DreamStation Go Auto with Bluetooth, Benelux-Netherlands
• 00606959048430: DreamStation Go Auto with Bluetooth, Nordics
• 00606959047310: DreamStation Go Auto CPAP, P-Flex with Bluetooth, France
• 00606959047266: DreamStation Go CPAP with Bluetooth, Battery, Domestic
• 00606959044487: DreamStation Go Auto with Bluetooth Spain-Portugal
• 00606959044470: DreamStation Go Auto CPAP with Bluetooth, Australia
• 00606959044463: DreamStation Go Auto CPAP with Bluetooth, Domestic
• 00606959044432: DreamStation Go CPAP with BT, Australia
• 00606959044425: DreamStation Go with Bluetooth, Domestic
• 00606959055889: DreamStation Go Heated Humidifier, International
• 00606959055926: DreamStation Go CPAP System with Heated Respiratory Humidifier, Canada
• 00606959054004: DreamStation Go Auto CPAP System with Humidifier, Canada
• 00606959053878: DreamStation Go Humidifier, Canada
• 00606959053892: DreamStation Go Humidifier, Canada
• 00606959055902: DreamStation Go Heated Humidifier, Eastern Europe
• 00606959055872: DreamStation Go Heated Humidifier, Central Europe
• 00606959055865: DreamStation Go Heated Humidifier, Nordics
• 00606959055933: DreamStation Go Home CPAP with Heated Respiratory Humidifier, Australia
• 00606959056930: DreamStation Go Auto CPAP with Bluetooth, Brazil
• 00606959056640: DreamStation Go Heated Respiratory Humidifier, Japan
• 00606959056626: DreamStation Go Heated Respiratory Humidifier, Brazil
• 00606959057098: DreamStation Go Auto with Bluetooth, Latin America
• 00606959057081: DreamStation Go Auto with Bluetooth, Argentina
• 00606959055940: DreamStation Go Home CPAP with Heated Respiratory Humidifier, Core Pack, Domestic
• 00606959054783: DreamStation Go CPAP with Humidifier, Domestic
• 00606959053991: DreamStation Go Auto CPAP with Humidifier, Domestic
• 00606959053861: DreamStation Go Heated Respiratory Humidifier, Domestic