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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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AF531 - 00606959007284

AF531 Mask with Standard Elbow with CapStrap, Single Use, Medium
Respironics, Inc.
AF531 Mask, SE with CapStrap, Medium, Single Use
Not in Commercial Distribution

  • 00606959007284 ()
1061731

  • CPAP/BPAP face mask, single-use

AF531 - 00606959007277

AF531 Mask with Standard Elbow with CapStrap, Single Use, Small
Respironics, Inc.
AF531 Mask, SE with CapStrap, Small, Single Use
Not in Commercial Distribution

  • 00606959007277 ()
1061730

  • CPAP/BPAP face mask, single-use

DreamWisp - 00606959051195

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 - 00606959051188

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 - 00606959051171

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 - 00606959051164

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

DreamWisp - 00606959051157

DreamWisp Nasal Mask, Petite with Small-Medium-Large Connector With Headgear, Japan
Respironics, Inc.
DreamWisp Mask, P, S-M-L Connector w/Hdgr, JN
In Commercial Distribution

  • 00606959051157 ()
1137947

  • CPAP/BPAP nasal mask, reusable

DreamWisp - 00606959051133

DreamWisp Nasal Mask, Large with Medium Connector with Headgear, International
Respironics, Inc.
DreamWisp Mask, Large, Med Connector, w/Headgear, INTL
In Commercial Distribution

  • 00606959051133 ()
1137945

  • CPAP/BPAP nasal mask, reusable

DreamWisp - 00606959051119

DreamWisp Nasal Mask, Small with Medium Connector with Headgear, International
Respironics, Inc.
DreamWisp Mask, Small, Med Connector, w/Headgear, INTL
In Commercial Distribution

  • 00606959051119 ()
1137943

  • CPAP/BPAP nasal mask, reusable

DreamWisp - 00606959051065

DreamWisp Nasal Mask, Small with Medium Connector, With Headgear, Global
Respironics, Inc.
DreamWisp Mask, Small, Med Connector w/Headgear, Global
In Commercial Distribution

  • 00606959051065 ()
1137933

  • CPAP/BPAP nasal mask, reusable
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