SEARCH RESULTS FOR: ("Japan enterprise-signed app-TG:@crmeb8🆑testflight-signed app.dcf")(774 results)

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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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AMARA MASK SE WITH RS FRAME AND HEADGEAR, LARGE, JAPAN
Respironics, Inc.
AMARA MASK w/SE w/RS FRAME and Headgr, Large, JN
Not in Commercial Distribution

  • 00606959025134 ()
1090256

  • CPAP/BPAP face mask, reusable
AMARA MASK SE WITH RS FRAME AND HEADGEAR, MEDIUM, JAPAN
Respironics, Inc.
AMARA MASK SE with RS FRAME and Headgear, Medium, Japan
Not in Commercial Distribution

  • 00606959025127 ()
1090255

  • CPAP/BPAP face mask, reusable
AMARA MASK WITH RS FRAME AND RS HEADGEAR SMALL, JAPAN
Respironics, Inc.
AMARA MASK with RS FRAME AND RS Headgear, Small, Japan
Not in Commercial Distribution

  • 00606959025073 ()
1090241

  • CPAP/BPAP face mask, reusable
AMARA MASK WITH RS FRAME AND RS HEADGEAR PETITE, JAPAN
Respironics, Inc.
AMARA MASK with RS FRAME and RS Headgear, Petite, Japan
Not in Commercial Distribution

  • 00606959025066 ()
1090240

  • CPAP/BPAP face mask, reusable
Amara View Mask with Standard Elbow, with Headgear, Large, Japan
Respironics, Inc.
Amara View Mask w/SE, with Headgear, Large, JP
In Commercial Distribution

  • 00606959024793 ()
1090654

  • CPAP/BPAP face mask, reusable
Amara View Mask with Standard Elbow, with Headgear, Medium, Japan
Respironics, Inc.
Amara View Mask w/SE, with Headgear, Medium, JP
In Commercial Distribution

  • 00606959024786 ()
1090653

  • CPAP/BPAP face mask, reusable
Amara View Mask with Standard Elbow, with Headgear, Small, Japan
Respironics, Inc.
Amara View Mask w/SE, with Headgear, Small, JP
In Commercial Distribution

  • 00606959024779 ()
1090652

  • CPAP/BPAP face mask, reusable
FitLife Mask with Standard Elbow, with Headgear, Extra Large, Japan
Respironics, Inc.
FitLife Mask with SE, with Headgear, XLarge, JP
Not in Commercial Distribution

  • 00606959023109 ()
1089997

  • CPAP/BPAP face mask, reusable
PerforMax Mask with Entrainment Elbow, Single Patient Use, Japan, Large
Respironics, Inc.
PerforMax Mask with EE, Single Patient Use, Large, JP
In Commercial Distribution

  • 30606959011855 ()
  • 00606959011854 ()
1055001

  • CPAP/BPAP face mask, single-use
FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, JAPAN w/SOFT CASE
METREX RESEARCH, LLC
910174-12
In Commercial Distribution

  • 00615375013267 ()


  • Surgical binoculars, reusable
ComfortGel Blue Full Mask with Standard Elbow, Extra Large, Japan
Respironics, Inc.
ComfortGel Blue Full Mask w/SE, Extra Large, Japan
Not in Commercial Distribution

  • 00606959043947 ()
1081853

  • CPAP/BPAP face mask, reusable
PN841 Mask, Child Med, with Standard Elbow, Single Use, japan
Respironics, Inc.
PN841 Mask, JPN, Child Med, SE, Single Use
Not in Commercial Distribution

  • 00606959041585 ()
1130571

  • CPAP/BPAP nasal mask, single-use
PN841 Mask, Child Small, with Standard Elbow, Single Use, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Small, SE, Single Use
Not in Commercial Distribution

  • 00606959041578 ()
1130570

  • CPAP/BPAP nasal mask, single-use
AF541 Mask with Standard Elbow with Capstrap, Size Large, Japan
Respironics, Inc.
AF541 Mask with SE, with Capstrap, Large, JP
Not in Commercial Distribution

  • 30606959041371 ()
  • 00606959041370 ()
1129506

  • CPAP/BPAP face mask, single-use
AF541 Mask with Standard Elbow with Capstrap, Size Medium, Japan
Respironics, Inc.
AF541 Mask with SE, with Capstrap, Medium, JP
Not in Commercial Distribution

  • 30606959041364 ()
  • 00606959041363 ()
1129505

  • CPAP/BPAP face mask, single-use
AF541 Mask with Standard Elbow, with Capstrap, Size Small, Japan
Respironics, Inc.
AF541 Mask with Standard Elbow, with Capstrap, Small, JP
Not in Commercial Distribution

  • 30606959041357 ()
  • 00606959041356 ()
1129504

  • CPAP/BPAP face mask, single-use
DreamWear Under the Nose Nasal, Medium Frame with Headgear, Japan
Respironics, Inc.
DreamWear Under Nose Mask, Med Frame w/Headgear, JP
Not in Commercial Distribution

  • 00606959040328 ()
1116730

  • CPAP/BPAP nasal mask, reusable
DreamWear Under Nose Mask, Wide, Large Frame with Headgear, Japan
Respironics, Inc.
DreamWear Under Nose Mask, Wide, L Frame w/Headgear, JP
Not in Commercial Distribution

  • 00606959040311 ()
1116728

  • CPAP/BPAP nasal mask, reusable
DreamWear Under Nose Mask, Wide, S Frame w/Headgear, Japan
Respironics, Inc.
DreamWear Under Nose Mask, Wide, S Frame w/Headgear, JP
Not in Commercial Distribution

  • 00606959040298 ()
1116724

  • CPAP/BPAP nasal mask, reusable
Wisp Nasal Mask with Headgear, Fabric Frame, Small Medium, Japan
Respironics, Inc.
Wisp Nasal Mask w/Headgear, Fabric Frame, Sm/Med, JP
Not in Commercial Distribution

  • 00606959040120 ()
1094072

  • CPAP/BPAP nasal mask, reusable
BiPAP Auto BiFlex with Humidifier, System One 60 Series, Japan
Respironics, Inc.
BiPAP Auto BiFlex w/Humid System One 60 Series, JP
Not in Commercial Distribution

  • 00606959031852 ()
JP766HS

  • Home BPAP unit
REMstar Auto A-Flex with Humidifier, System One 60 Series, Japan
Respironics, Inc.
REMstar Auto A-Flex w/Humid System One 60Series JP
Not in Commercial Distribution

  • 00606959030930 ()
JP566HS

  • Home CPAP unit
REMstar Pro C-Flex+, with Humidifier, System One 60 Series, Japan
Respironics, Inc.
REMstar Pro C-Flex+, w/Humid, System One 60Series, JP
Not in Commercial Distribution

  • 00606959030459 ()
JP466HS

  • Home CPAP unit
PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, LARGE, JAPAN
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, JP, LARGE
Not in Commercial Distribution

  • 30606959028433 ()
  • 00606959028432 ()
1126377

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL MASK, WITH STANDARD ELBOW WITH CAPSTRAP, MEDIUM, JAPAN
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, JP, MEDIUM
Not in Commercial Distribution

  • 30606959028419 ()
  • 00606959028418 ()
1126375

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL MASK WITH STANDARD ELBOW WITH CAPSTRAP, SMALL, JAPAN
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, JPN, SMALL
Not in Commercial Distribution

  • 30606959028396 ()
  • 00606959028395 ()
1126373

  • CPAP/BPAP face mask, single-use
DreamWisp Nasal, Extra Large with Small-Medium-Large Connector With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, XL, S-M-L Connector w/Hdgr, JN
Not in Commercial Distribution

  • 00606959051195 ()
1137951

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Large with Small-Medium-Large Connector With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, L, S-M-L Connector w/Hdgr, JN
In Commercial Distribution

  • 00606959051188 ()
1137950

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Medium with Small-Medium-Large Connector, With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, M, S-M-L Connector w/HDGR, JN
Not in Commercial Distribution

  • 00606959051171 ()
1137949

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal Mask, Small with Small-Medium-Large Connector With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, P, S-M-L Connector w/HDGR, JN
Not in Commercial Distribution

  • 00606959051164 ()
1137948

  • CPAP/BPAP nasal mask, reusable
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