System One 60 Series LA661S

GUDID 00606959031227

BiPAP Pro BiFlex, System One 60 Series, Latin America

Respironics, Inc.

Home BPAP unit

• Primary Device ID: 00606959031227
• NIH Device Record Key: 70cfbf36-6477-40cc-84c6-a50f94327850
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: System One 60 Series
• Version Model Number: 00
• Catalog Number: LA661S
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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	00606959031227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113068

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: 2016-08-20

On-Brand Devices [System One 60 Series]

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• 00606959021808: REMstar Auto A Flex, System One 60 Series, ND
• 00606959021792: REMstar Pro C Flex+, with Humidifier, System One 60 Series, ND
• 00606959021785: REMstar Pro C Flex+, System One 60 Series, ND
• 00606959021778: REMstar Plus C-Flex, with Humidifier, System One 60 Series, ND
• 00606959021761: REMstar Plus C-Flex, System One 60 Series, ND
• 00606959015302: REMstar Pro C-Flex+, BlueTooth, System One 60 Series, Domestic
• 00606959015159: REMstar Auto A-Flex, with Heated Tube Humidifier, System One 60 Series, China
• 00606959015142: REMstar Auto A-Flex, with Humidifier, System One 60 Series, China
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• 00606959015128: REMstar Pro C-Flex+, with Heated Tube Humidifier, System One 60 Series, China
• 00606959015111: REMstar Pro C-Flex+, with Humidifier, System One 60 Series, China
• 00606959015104: REMstar Pro C-Flex+, System One 60 Series, China
• 00606959015098: REMstar Plus C-Flex, with Heated Tube Humidifier, System One 60 Series, China
• 00606959015081: REMstar Plus C-Flex, with Humidifier, System One 60 Series, China
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• 00606959014350: BiPAP Auto BiFlex with Heated Tube Humidifier, System One 60 Series, China
• 00606959014343: BiPAP Auto BiFlex with Humidifier, System One 60 Series, China
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• 00606959014312: BiPAP Pro BiFlex with Humidifier System One 60 Series, China
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• 00606959014206: BiPAP Auto BiFlex with Heated Tube Humidifier, System One 60 Series, Canada
• 00606959014176: BiPAP Pro BiFlex with Humidifier, System One 60 Series, Canada
• 00606959014169: REMstar Auto A-Flex, with Heated Tube Humidifier, System One 60 Series, Canada
• 00606959014152: REMstar Auto A-Flex, System One 60 Series, Canada
• 00606959014145: REMstar Auto A-Flex with Humidifier, System One 60 Series, Canada
• 00606959014091: REMstar Pro C-Flex+, with Heated Tube Humidifier, System One 60 Series, Canada
• 00606959014084: REMstar Pro C-Flex+, with Heated Tube Humidifier, System One 60 Series, Canada
• 00606959006607: System One 60 Series Heated Humidifier, Domestic
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• 00606959006010: BiPAP Auto BiFlex with Humidifier, Sytem One 60 Series, Domestic
• 00606959006003: BiPAP Auto BiFlex, System One 60 Series, Domestic
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• 00606959005952: BiPAP Pro BiFlex, with Humidifier, System One 60 Series, Domestic
• 00606959005945: ,BiPAP Pro BiFlex, System One 60 Series, Domestic
• 00606959005938: BiPAP Pro BiFlex, with Heated Tube Humidifier, System One 60 Series AHP
• 00606959005921: BiPAP Pro BiFlex, with Heated Tube Humidifier, System One 60 Series, AHP
• 00606959005914: BiPAP Pro BiFlex, System One 60 Series, AHP
• 00606959005907: REMstar Auto A-Flex, with Humidifier, System One 60 Series, Domestic
• 00606959005891: REMstar Auto A-Flex, with Humidifier, System One 60 Series, Domestic
• 00606959005884: REMstar Auto A-Flex, System One 60 Series, Domestic
• 00606959005877: REMstar Auto A-Flex, with Heated Tube Humidifier, System One 60 Series, AHP