Dorma 500 AUV501H

GUDID 00606959049260

Dorma 500 Auto with Humidifier, Australia

Respironics, Inc.

Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier

• Primary Device ID: 00606959049260
• NIH Device Record Key: 73b8466a-15bd-4f42-8cf9-9b2ea9b84eb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dorma 500
• Version Model Number: 00
• Catalog Number: AUV501H
• 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: false
• 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
• 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 Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 140 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 60 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959049260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122769

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: 2017-12-01

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