COMFORTGEL BLUE 1081871

GUDID 00606959022263

Respironics, Inc.

CPAP/BPAP face mask, reusable

• Primary Device ID: 00606959022263
• NIH Device Record Key: 36877878-d075-4bd8-88cb-9248b319a992
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMFORTGEL BLUE
• Version Model Number: 00
• Catalog Number: 1081871
• Company DUNS: 080728314
• Company Name: Respironics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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.co

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959022263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073600

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: 2018-08-20
• Device Publish Date: 2015-11-06

On-Brand Devices [COMFORTGEL BLUE]

• 00606959022317: L COMFORTGEL BLUE NASAL MASK USA WHGR, DOM
• 00606959022300: M COMFORTGEL BLUE NASAL MASK USA WHGR, DOM
• 00606959022294: 00
• 00606959022263: 00