System One 60 Series NO561HS

GUDID 00606959030640

REMstar AutoA-Flex with Humidifier, System One 60 Series, NO

Respironics, Inc.

Home CPAP unit
Primary Device ID00606959030640
NIH Device Record Key4b8a71c3-0c10-49e1-84ff-c65a60079c81
Commercial Distribution StatusIn Commercial Distribution
Brand NameSystem One 60 Series
Version Model Number00
Catalog NumberNO561HS
Company DUNS080728314
Company NameRespironics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959030640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-13

On-Brand Devices [System One 60 Series]

00606959021853BiPAP Auto BiFlex with Humdifier System One 60 Series,ND
00606959021846BiPAP Auto BiFlex, System One 60 Series, ND
00606959021839BiPAP Pro BiFlex with Humidifier, System One 60 Series, ND
00606959021822BiPAP Pro BiFlex, System One 60 Series, ND
00606959021815REMstar Auto A Flex with Humidifier, System One 60 Series, ND
00606959021808REMstar Auto A Flex, System One 60 Series, ND
00606959021792REMstar Pro C Flex+, with Humidifier, System One 60 Series, ND
00606959021785REMstar Pro C Flex+, System One 60 Series, ND
00606959021778REMstar Plus C-Flex, with Humidifier, System One 60 Series, ND
00606959021761REMstar Plus C-Flex, System One 60 Series, ND
00606959015302REMstar Pro C-Flex+, BlueTooth, System One 60 Series, Domestic
00606959015159REMstar Auto A-Flex, with Heated Tube Humidifier, System One 60 Series, China
00606959015142REMstar Auto A-Flex, with Humidifier, System One 60 Series, China
00606959015135REMstar Auto A-Flex, System One, 60 Series, China
00606959015128REMstar Pro C-Flex+, with Heated Tube Humidifier, System One 60 Series, China
00606959015111REMstar Pro C-Flex+, with Humidifier, System One 60 Series, China
00606959015104REMstar Pro C-Flex+, System One 60 Series, China
00606959015098REMstar Plus C-Flex, with Heated Tube Humidifier, System One 60 Series, China
00606959015081REMstar Plus C-Flex, with Humidifier, System One 60 Series, China
00606959015074REMstar Plus C-Flex, System One 60 Series, China
00606959014350BiPAP Auto BiFlex with Heated Tube Humidifier, System One 60 Series, China
00606959014343BiPAP Auto BiFlex with Humidifier, System One 60 Series, China
00606959014336BiPAP Auto BiFlex, System One 60 Series, China
00606959014329BiPAP Pro BiFlex with Heated Tube Humidifier, System One 60 Series, China
00606959014312BiPAP Pro BiFlex with Humidifier System One 60 Series, China
00606959014305BiPAP Pro BiFlex, System One 60 Series, China
00606959014206BiPAP Auto BiFlex with Heated Tube Humidifier, System One 60 Series, Canada
00606959014176BiPAP Pro BiFlex with Humidifier, System One 60 Series, Canada
00606959014169REMstar Auto A-Flex, with Heated Tube Humidifier, System One 60 Series, Canada
00606959014152REMstar Auto A-Flex, System One 60 Series, Canada
00606959014145REMstar Auto A-Flex with Humidifier, System One 60 Series, Canada
00606959014091REMstar Pro C-Flex+, with Heated Tube Humidifier, System One 60 Series, Canada
00606959014084REMstar Pro C-Flex+, with Heated Tube Humidifier, System One 60 Series, Canada
00606959006607System One 60 Series Heated Humidifier, Domestic
00606959006027BiPAP Auto BiFlex with Heated Tube Humidifier, System One 60 Series, Domestic
00606959006010BiPAP Auto BiFlex with Humidifier, Sytem One 60 Series, Domestic
00606959006003BiPAP Auto BiFlex, System One 60 Series, Domestic
00606959005990BiPAP Auto BiFlex with Heated Tube Humidifier System One 60 Series, AHP
00606959005983BiPAP Auto BiFlex with Humidifier System One 60 Series, AHP
00606959005976BiPAP Auto BiFlex, System One 60 Series, AHP
00606959005969BiPAP Pro BiFlex, with Heated Tube Humidifier, System One 60 Series, Domestic
00606959005952BiPAP Pro BiFlex, with Humidifier, System One 60 Series, Domestic
00606959005945,BiPAP Pro BiFlex, System One 60 Series, Domestic
00606959005938BiPAP Pro BiFlex, with Heated Tube Humidifier, System One 60 Series AHP
00606959005921BiPAP Pro BiFlex, with Heated Tube Humidifier, System One 60 Series, AHP
00606959005914BiPAP Pro BiFlex, System One 60 Series, AHP
00606959005907REMstar Auto A-Flex, with Humidifier, System One 60 Series, Domestic
00606959005891REMstar Auto A-Flex, with Humidifier, System One 60 Series, Domestic
00606959005884REMstar Auto A-Flex, System One 60 Series, Domestic
00606959005877REMstar Auto A-Flex, with Heated Tube Humidifier, System One 60 Series, AHP

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