DreamStation Go Auto FRG503S14

GUDID 00606959048621

DreamStation Go Auto with Bluetooth, Flagship Store, France

Respironics, Inc.

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• Primary Device ID: 00606959048621
• NIH Device Record Key: 04b92cdc-66e3-4eed-aa5d-c16af2db7b25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamStation Go Auto
• Version Model Number: AUTO BT
• Catalog Number: FRG503S14
• 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
• 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 Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959048621 [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 Auto]

• 00606959050181: DreamStation Go Auto with Bluetooth, Hong Kong
• 00606959048706: DreamStation Go Auto CPAP with Bluetooth, Japan
• 00606959048676: DreamStation Go Auto with Bluetooth, Flagship Store, Great Britian
• 00606959048621: DreamStation Go Auto with Bluetooth, Flagship Store, France
• 00606959048614: DreamStatio Go Auto with Bluetooth, Canada
• 00606959048447: DreamStation Go Auto, with Bluetooth, Nordics
• 00606959044494: DreamStation Go Auto, Spain Portugal