Dorma 507V

GUDID 00606959038530

Dorma 500 Auto CPAP System, China

Respironics, Inc.

Home CPAP unit

• Primary Device ID: 00606959038530
• NIH Device Record Key: 80031836-9bde-4f60-8fcb-14068008bb35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dorma
• Version Model Number: 507V
• Catalog Number: 507V
• 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)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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959038530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130077

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: 2019-04-17
• Device Publish Date: 2019-04-09

On-Brand Devices [Dorma]

• 00606959048287: Dorma 200, Italy
• 00606959048270: Dorma 100, Italy
• 00606959038530: Dorma 500 Auto CPAP System, China
• 00606959038639: Dorma 500 Auto CPAP System, China
• 00606959038592: Dorma 200 CPAP System, China