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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 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 Nasal, Medium with Medium Connector with Headgear, Asia Pacific
Respironics, Inc.
DreamWisp Mask, Medium, Med Connector w/Headgear, APr, AP
In Commercial Distribution

  • 00606959057258 ()
1137944AP

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal, Petite with Medium Connector with Headgear, Asia Pacific
Respironics, Inc.
DreamWisp Mask, Petite, Med Connector w/Headgear, AP
In Commercial Distribution

  • 00606959057234 ()
1137942AP

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal, Large with Medium Connector with Headgear, Asia Pacific
Respironics, Inc.
DreamWisp Mask, Large, Med Connector w/Headgear, AP
In Commercial Distribution

  • 00606959057265 ()
1137945AP

  • CPAP/BPAP nasal mask, reusable
DreamWisp Nasal, Small with Medium Connector with Headgear, Asia Pacific
Respironics, Inc.
DreamWisp Mask, Small, Med Connector w/Headgear, AP
In Commercial Distribution

  • 00606959057241 ()
1137943AP

  • CPAP/BPAP nasal mask, reusable
DreamWisp Mask, Large with Small/Medium Connector, with Headgear, Korea
Respironics, Inc.
DreamWisp Mask, L, Sm/Med Connector, W/Headgear, KR
Not in Commercial Distribution

  • 00606959054486 ()
1139335

  • CPAP/BPAP nasal mask, reusable
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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