A Series Heated Humidifier 1112116

GUDID 00606959042810

BiPAP Silver Series Heated Humidifier FGD SA, DE

Respironics, Inc.

Heated respiratory humidifier

• Primary Device ID: 00606959042810
• NIH Device Record Key: c8192645-3eab-4274-bca5-5daa0485158a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A Series Heated Humidifier
• Version Model Number: 00
• Catalog Number: 1112116
• 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	00606959042810 [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 Heated Humidifier]

• 00606959021563: A Series System One Heated Tube Humidifier, International
• 00606959021556: A Series System One Heated Humidifier, International
• 00606959045316: A Series, Sys One,Heated Humidifier, Domestic -Rental
• 00606959042810: BiPAP Silver Series Heated Humidifier FGD SA, DE
• 00606959041035: A Series System One Heated Tube Humidifier, Japan
• 00606959041028: A Series System One Heated Humidifier, Japan
• 00606959032088: BiPAP A Series Heated Humidifier FGD SA Domestic
• 00606959032064: BiPAP A Series, System One Heated Humidifier, FGD SA
• 00606959032026: BiPAP A Series Heated Humidifier FGD SA International