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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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REMstar System One 60 Series - 00606959030695

REMstar Auto A-Flex, System One 60 Series, PT
Respironics, Inc.
REMstar Auto A-Flex, System One 60 Series, PT
In Commercial Distribution

  • 00606959030695 ()
PT561S

  • Home CPAP unit

REMstar System One 60 Series - 00606959030664

REMstar Auto A-Flex, System One 60 Series, ES
Respironics, Inc.
REMstar Auto A-Flex, System One 60 Series, ES
In Commercial Distribution

  • 00606959030664 ()
ES561S

  • Home CPAP unit

REMstar System One 60 Series - 00606959030657

REMstar auto A-Flex, System One 60 Series, NO
Respironics, Inc.
REMstar Auto A-Flex, System One 60 Series, NO
In Commercial Distribution

  • 00606959030657 ()
NO561S

  • Home CPAP unit

REMstar System One 60 Series - 00606959030626

REMstar Auto A-Flex, System One 60 Series, SE
Respironics, Inc.
REMstar Auto A-Flex, System One 60 Series, SE
In Commercial Distribution

  • 00606959030626 ()
SE561S

  • Home CPAP unit

REMstar System One 60 Series - 00606959030602

REMstar Auto A-Flex, System One 60 Series, FI
Respironics, Inc.
REMstar Auto A-Flex, System One 60 Series, FI
In Commercial Distribution

  • 00606959030602 ()
FI561S

  • Home CPAP unit

REMstar System One 60 Series - 00606959030503

REMstar Auto A-Flex, System One 60 Series, Germany
Respironics, Inc.
REMstar Auto A-Flex, System One 60 Series, Germany
Not in Commercial Distribution

  • 00606959030503 ()
DE562S

  • Home CPAP unit

REMstar System One 60 Series - 00606959030466

REMstar Pro C-Flex+, System One 60 Series, Japan
Respironics, Inc.
REMstar Pro C-Flex+, System One 60Series, JP
Not in Commercial Distribution

  • 00606959030466 ()
JP466S

  • Home CPAP unit

REMstar System One 60 Series - 00606959030411

REMstar Pro C-Flex+, System One 60 Series, FR
Respironics, Inc.
REMstar Pro C-Flex+ System One, 60 Series, FR
In Commercial Distribution

  • 00606959030411 ()
FR465S

  • Home CPAP unit

REMstar System One 60 Series - 00606959030398

REMstar Pro C-Flex+, System One 60 Series, PT
Respironics, Inc.
REMstar Pro C-Flex+, System One 60 Series, PT
In Commercial Distribution

  • 00606959030398 ()
PT461S

  • Home CPAP unit

System One 60 Series - 00606959030374

REMstar Pro C-Flex+, System One 60 Series, ES
Respironics, Inc.
REMstar Pro C-Flex+, System One 60 Series, ES
In Commercial Distribution

  • 00606959030374 ()
ES461S

  • Home CPAP unit

REMstar System One 60 Series - 00606959030350

REMstar Pro C-Flex+, System One 60 Series, SE
Respironics, Inc.
REMstar Pro C-Flex+, System One 60 Series, SE
In Commercial Distribution

  • 00606959030350 ()
SE461S

  • Home CPAP unit

REMstar System One 60 Series - 00606959030329

REMstar Pro C-Flex+, System One 60 Series, GB
Respironics, Inc.
REMstar Pro C-Flex+, System One 60 Series, GB
In Commercial Distribution

  • 00606959030329 ()
GB461S

  • Home CPAP unit

REMstar System One 60 Series - 00606959030237

REMstar Pro C-Flex, System One 60 Series, France
Respironics, Inc.
REMstar Pro C-Flex, System One 60 Series, France
Not in Commercial Distribution

  • 00606959030237 ()
FR365S

  • Home CPAP unit

REMstar System One 60 Series - 00606959030220

REMstar Pro C-Flex+, System One 60 Series, Germany
Respironics, Inc.
REMstar Pro C-Flex+, System One 60 Series, Germany
Not in Commercial Distribution

  • 00606959030220 ()
DE462S

  • Home CPAP unit

REMstar System One 60 Series - 00606959030145

REMstar Pro C-Flex+, System One 60 Series, Canada
Respironics, Inc.
REMstar Pro C-Flex+, 60 Series, CA
In Commercial Distribution

  • 00606959030145 ()
CA461S

  • Home CPAP unit

BiPAP autoSV Advanced System One 60 Series - 00606959029743

BiPAP autoSV Advanced System One 60 Series, Japan
Respironics, Inc.
BiPAP autoSV Advanced, 60 Series, JP
Not in Commercial Distribution

  • 00606959029743 ()
JP966S

  • Portable electric ventilator

BiPAP autoSV Advanced System One 60 Series - 00606959029712

BiPAP autoSV Advanced System One 60 Series, France
Respironics, Inc.
BiPAP autoSV Advanced, 60 Series, FR
Not in Commercial Distribution

  • 00606959029712 ()
FR965S

  • Portable electric ventilator

A Series - 00606959039636

A Series System One Heated Tube Humidifier, US
Respironics, Inc.
A Series System One Heated Tube Humidifier, US
In Commercial Distribution

  • 00606959039636 ()
1111554

  • Heated respiratory humidifier

BiPAP autoSV Advanced System One 60 Series - 00606959038202

BiPAP autoSV Advanced System One 60 Series, Japan
Respironics, Inc.
BiPAP autoSV Advanced System One, 60 Series, JP
Not in Commercial Distribution

  • 00606959038202 ()
966P

  • Portable electric ventilator

BiPAP autoSV Advanced System One 60 Series - 00606959038196

BiPAP autoSV Advanced System One 60 Series, Germany
Respironics, Inc.
BiPAP autoSV Advanced System One, 60 Series, DE
In Commercial Distribution

  • 00606959038196 ()
962P

  • Portable electric ventilator

REMstar System One 60 Series - 00606959037922

REMstar Pro C-Flex, System One 60 Series, France
Respironics, Inc.
REMstar Pro C-Flex, System One 60 Series, FR
Not in Commercial Distribution

  • 00606959037922 ()
365P

  • Home CPAP unit

REMstar System One, 60 Series - 00606959037915

REMstar Auto A-Flex, System One 60 Series, France
Respironics, Inc.
REMstar Auto A-Flex, System One 60 Series, FR
Not in Commercial Distribution

  • 00606959037915 ()
565P

  • Home CPAP unit

REMstar System One 60 Series - 00606959037892

REMstar Auto A-Flex, System One, 60 Series, Germany
Respironics, Inc.
REMstar Auto A-Flex, System One, 60 Series, DE
Not in Commercial Distribution

  • 00606959037892 ()
562P

  • Home CPAP unit

REMstar System One 60 Series - 00606959037861

REMstar Pro C-Flex+, System One 60 Series, Germany
Respironics, Inc.
REMstar Pro C-Flex+, System One 60 Series, DE
Not in Commercial Distribution

  • 00606959037861 ()
462P

  • Home CPAP unit

A Series Heated Humidifier - 00606959032064

BiPAP A Series, System One Heated Humidifier, Japan
Respironics, Inc.
BiPAP A Series, System One Heated Humidifier, JP
Not in Commercial Distribution

  • 00606959032064 ()
1111548

  • Heated respiratory humidifier

BiPAP autoSV Advanced System One 60 Series - 00606959032002

BiPAP autoSV Advanced System One 60 Series, China
Respironics, Inc.
BiPAP autoSV Advanced System One, 60 Series, CN
Not in Commercial Distribution

  • 00606959032002 ()
967P

  • Portable electric ventilator

BiPAP autoSV Advanced System One 60 Series - 00606959031999

BiPAP autoSV Advanced System One 60 Series, France
Respironics, Inc.
BiPAP autoSV Advanced, 60 Series, FR
Not in Commercial Distribution

  • 00606959031999 ()
965P

  • Portable electric ventilator

BiPAP autoSV Advanced System One 60 Series - 00606959031975

BiPAP autoSV Advanced System One 60 Series, International
Respironics, Inc.
BiPAP autoSV Advanced System One, 60 Series, INTL
In Commercial Distribution

  • 00606959031975 ()
961P

  • Portable electric ventilator

BiPAP autoSV Advanced System One 60 Series - 00606959031968

BiPAP autoSV Advanced System One, 60 Series, USA
Respironics, Inc.
BiPAP autoSV Advanced System One, 60 Series, US
In Commercial Distribution

  • 00606959031968 ()
960P

  • Portable electric ventilator

BiPAP System One 60 Series - 00606959031838

BiPAP Auto BiFlex, System One 60 Series, FR
Respironics, Inc.
BiPAP Auto BiFlex, System One 60 Series, FR
Not in Commercial Distribution

  • 00606959031838 ()
FR765S

  • Home BPAP unit

BiPAP System One 60 Series - 00606959021822

BiPAP Pro BiFlex, System One 60 Series, ND
Respironics, Inc.
BiPAP Pro BiFlex, System One 60 Series, ND
In Commercial Distribution

  • 00606959021822 ()
ND661S

  • Home BPAP unit

REMstar System One 60 Series - 00606959021761

REMstar Plus C-Flex, System One 60 Series, ND
Respironics, Inc.
REMstar Plus CFlex, Sys One, 60 Series, ND
In Commercial Distribution

  • 00606959021761 ()
ND261S

  • Home CPAP unit

A Series - 00606959021563

A Series System One Heated Tube Humidifier, International
Respironics, Inc.
A Series System One Heated Tube Humidifier, INTL
In Commercial Distribution

  • 00606959021563 ()
1111555

  • Heated respiratory humidifier

BiPAP autoSV Advanced System One 60 Series - 00606959021938

BiPAP autoSV Advanced System One 60 Series, AHP
Respironics, Inc.
BiPAP autoSV Advanced System One, 60 Series, AHP
In Commercial Distribution

  • 00606959021938 ()
AH960S

  • Portable electric ventilator

BiPAP autoSV Advanced System One 60 Series - 00606959021921

BiPAP autoSV Advanced System One 60 Series, Brazil
Respironics, Inc.
BiPAP autoSV Advanced System One 60 Series, BR
Not in Commercial Distribution

  • 00606959021921 ()
BR969S

  • Portable electric ventilator

BiPAP System One 60 Series - 00606959021846

BiPAP Auto BiFlex, System One 60 Series, ND
Respironics, Inc.
BiPAP Auto BiFlex, System One 60 Series, ND
In Commercial Distribution

  • 00606959021846 ()
ND761S

  • Home BPAP unit

REMstar System One 60 Series - 00606959015135

REMstar Auto A-Flex, System One, 60 Series, China
Respironics, Inc.
REMstar Auto A-Flex, System One, 60 Series CN
Not in Commercial Distribution

  • 00606959015135 ()
CN567S

  • Home CPAP unit

REmstar System One 60 Series - 00606959015104

REMstar Pro C-Flex+, System One 60 Series, China
Respironics, Inc.
REMstar Pro C-Flex+, System One 60 Series CN
Not in Commercial Distribution

  • 00606959015104 ()
CN467S

  • Home CPAP unit

REMstar System One 60 Series - 00606959015074

REMstar Plus C-Flex, System One 60 Series, China
Respironics, Inc.
REMstar Plus C-Flex, System One, 60 Series CN
Not in Commercial Distribution

  • 00606959015074 ()
CN267S

  • Home CPAP unit

BiPAP autoSV Advanced System One 60 Series - 00606959015043

BiPAP autoSV Advanced System One 60 Series, China
Respironics, Inc.
BiPAP autoSV Advanced, 60 Series,CN
Not in Commercial Distribution

  • 00606959015043 ()
CN967S

  • Portable electric ventilator

A Series Heated Humidifier - 00606959045316

A Series, Sys One,Heated Humidifier, Domestic -Rental
Respironics, Inc.
00
In Commercial Distribution

  • 00606959045316 ()
R1111551

  • Heated respiratory humidifier

A Series - 00606959041035

A Series System One Heated Tube Humidifier, Japan
Respironics, Inc.
A Series System One Heated Tube Humidifier, Japan
In Commercial Distribution

  • 00606959041035 ()
1111556

  • Heated respiratory humidifier

BiPAP autoSV Advanced System One 60 Series - 00606959006201

BiPAP autoSV Advanced System One 60 Series, Australia
Respironics, Inc.
BiPAP autoSV Advanced System One 60 Series, AU
Not in Commercial Distribution

  • 00606959006201 ()
AU961S

  • Portable electric ventilator

BiPAP System One 60 Series - 00606959006003

BiPAP Auto BiFlex, System One 60 Series, USA
Respironics, Inc.
BiPAP Auto BiFlex System One 60 Series,US
Not in Commercial Distribution

  • 00606959006003 ()
DS760S

  • Home BPAP unit

BiPAP System One 60 Series - 00606959005976

BiPAP Auto BiFlex, System One 60 Series, AHP
Respironics, Inc.
BiPAP Auto BiFlex System One 60 Series, AHP
In Commercial Distribution

  • 00606959005976 ()
AH760S

  • Home BPAP unit

BiPAP System One 60 Series - 00606959005945

,BiPAP Pro BiFlex, System One 60 Series, USA
Respironics, Inc.
BiPAP Pro BiFlex System One 60 Series US
In Commercial Distribution

  • 00606959005945 ()
DS660S

  • Home BPAP unit

BiPAP System One 60 Series - 00606959005914

BiPAP Pro BiFlex, System One 60 Series, AHP
Respironics, Inc.
BiPAP Pro BiFlex, System One 60 Series, AHP
In Commercial Distribution

  • 00606959005914 ()
AH660S

  • Home BPAP unit

REMstar System One 60 Series - 00606959005884

REMstar Auto A-Flex, System One 60 Series, USA
Respironics, Inc.
REMstar Auto A-Flex System One 60 Series US
Not in Commercial Distribution

  • 00606959005884 ()
DS560S

  • Home CPAP unit

REMstar System One 60 Series - 00606959005853

REMstar Auto A-Flex, System One 60 Series, AHP
Respironics, Inc.
REMstar Auto A-Flex, 60 Series, AHP
In Commercial Distribution

  • 00606959005853 ()
AH560S

  • Home CPAP unit

REMstar System One 60 Series - 00606959005822

REMstar Pro C-Flex+, System One 60 Series, USA
Respironics, Inc.
REMstar Pro C-Flex+ System One 60 Series US
Not in Commercial Distribution

  • 00606959005822 ()
DS460S

  • Home CPAP unit
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