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

  • 00606959031272 ()
FI661S

  • Home BPAP unit
BiPAP Pro BiFlex, System One 60 Series, GB
Respironics, Inc.
BiPAP Pro BiFlex, System One 60 Series, GB
In Commercial Distribution

  • 00606959031258 ()
GB661S

  • Home BPAP unit
BiPAP Pro BiFlex, System One 60 Series, International
Respironics, Inc.
BiPAP Pro BiFlex System One 60 Series INT
In Commercial Distribution

  • 00606959031197 ()
IN661S

  • Home BPAP unit
REMstar Auto P-Flex, System One 60 Series, France
Respironics, Inc.
REMstar Auto P-Flex, System One 60 Series, France
Not in Commercial Distribution

  • 00606959030978 ()
FR568S

  • Home CPAP unit
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 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 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 Pro C-Flex+, System One 60 Series, International
Respironics, Inc.
REMstar Pro C-Flex+, 60 Series, INTL
In Commercial Distribution

  • 00606959030251 ()
IN461S

  • Home CPAP unit
SOMNIA 3i C-Flex+, System One 60 Series, HL
Respironics, Inc.
SOMNIA 3i C-Flex+ System One 60 Series H&L
In Commercial Distribution

  • 00606959030244 ()
HL464S

  • Home CPAP unit
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 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 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
REMstar Plus C-Flex, System One 60 Series, GB
Respironics, Inc.
REMstar Plus C-Flex, System One 60 Series, GB
In Commercial Distribution

  • 00606959029941 ()
GB261S

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

  • 00606959031968 ()
960P

  • Portable electric ventilator
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 Auto BiFlex, System One 60 Series, Germany
Respironics, Inc.
BiPAP Auto BiFlex, System One 60 Series, DE
Not in Commercial Distribution

  • 00606959031814 ()
DE762S

  • Home BPAP unit
REMstar Auto A-Flex System One 60 Series, LA
Respironics, Inc.
REMstar Auto A-Flex System One 60 Series LA
Not in Commercial Distribution

  • 00606959030794 ()
LA561S

  • Home CPAP unit
REMstar Auto A-Flex System One 60 Series, International
Respironics, Inc.
REMstar Auto A-Flex, 60 Series, INTL
In Commercial Distribution

  • 00606959030756 ()
IN561S

  • Home CPAP unit
REMstar Auto A-Flex System One 60 Series, FR
Respironics, Inc.
REMstar Auto A-Flex System One 60 Series FR
Not in Commercial Distribution

  • 00606959030725 ()
FR565S

  • Home CPAP unit
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 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 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 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 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 Auto A-Flex, System One 60 Series, GB
Respironics, Inc.
REMstar Auto A-Flex, System One 60 Series, GB
In Commercial Distribution

  • 00606959030589 ()
GB561S

  • Home CPAP unit
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 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
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 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 Pro C-Flex+, System One 60 Series, FI
Respironics, Inc.
REMstar Pro C-Flex+, System One 60 Series, FI
In Commercial Distribution

  • 00606959030336 ()
FI461S

  • Home CPAP unit
REMstar Plus C-Flex, System One 60 Series, International
Respironics, Inc.
REMstar Plus C-Flex, 60 Series, INTL
In Commercial Distribution

  • 00606959029880 ()
IN261S

  • Home CPAP unit
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, France
Respironics, Inc.
BiPAP autoSV Advanced, 60 Series, FR
Not in Commercial Distribution

  • 00606959029712 ()
FR965S

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

  • 00606959029620 ()
IN961S

  • Portable electric ventilator
BiPAP autoSV Advanced System One 60 Series, Canada
Respironics, Inc.
BiPAP autoSV Advanced 60 Series, CA
In Commercial Distribution

  • 00606959029606 ()
CA961S

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

  • 00606959045316 ()
R1111551

  • Heated respiratory humidifier
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
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
OPTIGLAZE™ OPTIGLAZE Contains: One (15 mL) bottle.
Gc America Inc.
002613
In Commercial Distribution

  • D0470026131 ()

  • Total Volume: 15 Milliliter
002613

  • Dental unfilled resin sealant/coating
ACCLEAN ONE STEP FLUORIDE VARNISH BUBBLE GUM -200ct
HENRY SCHEIN, INC.
5700523
In Commercial Distribution

  • 10304040040499 ()
  • 00304040040492 ()
  • 20304040040496 ()

  • Total Volume: 0.4 Milliliter
5700523

  • Dental coating, tooth-desensitizing
Walgreens Exam Gloves One Size Fits Most 100ct
WALGREEN CO.
296462
In Commercial Distribution

  • 00311917006239 ()
  • 10311917006236 ()
  • 60311917006231 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
One Material Thousand Shades - Light Cure Restorative Composite
First Scientific Dental Materials GmbH
10-007
In Commercial Distribution

  • EFSM100070 ()


  • Dental composite resin
ACCLEAN ONE STEP FLUORIDE VARNISH BUBBLE GUM -50ct
HENRY SCHEIN, INC.
5700528
In Commercial Distribution

  • 10304040040444 ()
  • 00304040040447 ()
  • 20304040040441 ()

  • Total Volume: 0.4 Milliliter
5700528

  • Dental coating, tooth-desensitizing
One Step Menopause Test - 1 Test With Insert
WALGREEN CO.
MidStream 6
In Commercial Distribution

  • 00311917215754 ()
  • 10311917215751 ()


  • Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
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