Dorma 500 CNV507HN1

GUDID 00606959040410

Dorma 500 Auto, with Humidifier, Pico, China

Respironics, Inc.

Heated respiratory humidifier

• Primary Device ID: 00606959040410
• NIH Device Record Key: a5ac416a-a1dd-4f04-a1cd-99b8db0ed6a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dorma 500
• Version Model Number: 00
• Catalog Number: CNV507HN1
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959040410 [Primary]

FDA Product Code

• BZD: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-26
• Device Publish Date: 2019-04-18

On-Brand Devices [Dorma 500]

• 00606959049260: Dorma 500 Auto with Humidifier, Australia
• 00606959049253: Dorma 500 Auto, Australia
• 00606959038653: Dorma 500 Auto, Brazil
• 00606959038646: Dorma 500 Auto with Humidifier, China
• 00606959038547: Dorma 500 Auto, Brazil
• 00606959038523: Dorma 500 Auto, Germany
• 00606959038516: Dorma 500 Auto, International
• 00606959038509: Dorma 500 Auto, Canada
• 00606959037076: Dorma 500 Auto with Humidifier, TR
• 00606959037069: Dorma 500 Auto, TR
• 00606959037021: Dorma 500 Auto with Humidifier, LA
• 00606959037014: Dorma 500 Auto, LA
• 00606959036956: Dorma 500 Auto with Humidifier, International
• 00606959036949: Dorma 500 Auto, International
• 00606959036864: Dorma 500 Auto with Humidifier, IND
• 00606959036857: Dorma 500 Auto, India
• 00606959036840: Dorma 500 Auto with Humidifier, Germany
• 00606959036833: Dorma 500 Auto, Germany
• 00606959036741: Dorma 500 Auto with Humidifier, Canada
• 00606959036734: Dorma 500 Auto, Canada
• 00606959040410: Dorma 500 Auto, with Humidifier, Pico, China