DreamStation BiPAP AVAPS CAX1130S12C

GUDID 00606959425545

DreamStation BiPAP AVAPS30 with Cell Modem, Canada

Respironics, Inc.

Portable electric ventilator

• Primary Device ID: 00606959425545
• NIH Device Record Key: fba915e1-a88a-4140-b22f-1820c2340b71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamStation BiPAP AVAPS
• Version Model Number: DreamStation BiPAP AVAPS30 w/Cell, CA
• Catalog Number: CAX1130S12C
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959425545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102465

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: 2025-08-12
• Device Publish Date: 2017-02-10

On-Brand Devices [DreamStation BiPAP AVAPS]

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• 00606959045644: DreamStation BiPAP AVAPS30 with Cell, DOM
• 00606959045637: DreamStation BiPAP AVAPS30 with Humidifier, with Heated Tubing, with WiFi, DOM
• 00606959045620: DreamStation BiPAP AVAPS30 with Humidifier, with WiFi, DOM
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• 00606959426009: DreamStation BiPAP AVAPS 30 Great Britain
• 00606959425583: DreamStation BiPAP AVAPS30 with Humidifier, with Heated Tube, with WiFi, Canada
• 00606959425576: DreamStation BiPAP AVAPS30 AAM, with WiFi, Canada
• 00606959425569: DreamStation BiPAP AVAPS30 AAM with Humidifier, with WiFi, Canada
• 00606959425552: DreamStation BiPAP AVAPS30 with Humidifier, with Heated Tube, with Cell Modem, Canada
• 00606959425545: DreamStation BiPAP AVAPS30 with Cell Modem, Canada
• 00606959425538: DreamStation BiPAP AVAPS30 with Humidifier, with Cell Modem, Canada
• 00606959424999: DreamStation BiPAP AVAPS30 AE with Humidifier, with Heated Tube, with WiFi, Australia
• 00606959424982: DreamStation BiPAP AVAPS30 AE with WiFi, Australia
• 00606959424975: DreamStation BiPAP AVAPS30 AE with Humidifier with WiFi, Australia
• 00606959424968: DreamStation BiPAP AVAPS30 AE with Humdifier, with Heated Tube, with Cell Modem, Australia
• 00606959424951: DreamStation BiPAP AVAPS30 AE with Cell Modem, Australia
• 00606959424944: DreamStation BiPAP AVAPS30 AE with Humidifier, with Cell Modem, Australia