A Series Humidifier 1112092

GUDID 00606959042803

BiPAP Silver Series Humidifier FGD SA, DE

Respironics, Inc.

Heated respiratory humidifier

• Primary Device ID: 00606959042803
• NIH Device Record Key: 7fb12ab3-f048-47c2-823c-3126411fcc14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A Series Humidifier
• Version Model Number: 00
• Catalog Number: 1112092
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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	00606959042803 [Primary]

FDA Product Code

• MNT: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-31

On-Brand Devices [A Series Humidifier]

• 00606959013872: A Series Humidifer, International
• 00606959043282: A Series Humidifier, FGD SA, International
• 00606959042803: BiPAP Silver Series Humidifier FGD SA, DE
• 00606959032071: A Series, System One Heated Humdifier, FGD SA, Domestic
• 00606959032057: BiPAP A Series, System One Humidifier, FGD SA, JP
• 00606959032019: BiPAP A Series System One Humidifier, FGD SA, International
• 00606959061958: Hum, A Series, Sys One, Flow Gen, CN