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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 SE with Heated Humidifier, Standard Tube, with SD Slot, Canada
Respironics, Inc.
REMstar SE w/HTD Humid, St Tube, with SD Slot, CA
In Commercial Distribution

  • 00606959020092 ()
CA221NTS

  • Home CPAP unit
  • Heated respiratory humidifier
AF531, with Entrainment Elbow (Nebulizing Elbow), with CapStrap HeadGear, Medium, USA
Respironics, Inc.
AF531 Mask EE (NE) with CapStrap, Medium, USA
Not in Commercial Distribution

  • 30606959012388 ()
  • 00606959012387 ()
1094815

  • CPAP/BPAP face mask, single-use
AF531, with Entrainment Elbow (Nebulizing Elbow), with CapStrap HeadGear, Small, USA
Respironics, Inc.
AF531 Mask EE (NE) with CapStrap, Small, USA
In Commercial Distribution

  • 30606959012371 ()
  • 00606959012370 ()
1094814

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, with 4 Point Headgear, Large, USA
Respironics, Inc.
AF531 Mask w/SE, with 4 Point Headgear, Large, USA
In Commercial Distribution

  • 30606959012333 ()
  • 00606959012332 ()
1094810

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, with 4 Point Headgear, Medium, USA
Respironics, Inc.
AF531 Mask w/SE, with 4 PT Headgear, Medium, USA
Not in Commercial Distribution

  • 30606959012326 ()
  • 00606959012325 ()
1094809

  • CPAP/BPAP face mask, single-use
AF531 Mask with Standard Elbow, with 4 Point Headgear, Small, USA
Respironics, Inc.
AF531 Mask w/SE, w/4 PT Headgear, Small, USA
In Commercial Distribution

  • 30606959012319 ()
  • 00606959012318 ()
1094808

  • CPAP/BPAP face mask, single-use
DreamWisp Nasal, Petite with Medium Connector with Headgear, Central Eastern Europe
Respironics, Inc.
DreamWisp Mask, Petite, Med Connector w/Headgear, CEE
In Commercial Distribution

  • 00606959057289 ()
1137942CE

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

  • 00606959057272 ()
1137946AP

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

  • 00606959054479 ()
1139334

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

  • 00606959054462 ()
1139333

  • CPAP/BPAP nasal mask, reusable
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