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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 - 00606959012271

AF531 Mask with Entrainment Elbow, with CapStrap, Large, USA
Respironics, Inc.
AF531 Mask EE with CapStrap, Large, USA
In Commercial Distribution

  • 30606959012272 ()
  • 00606959012271 ()
1094804

  • CPAP/BPAP face mask, single-use

AF531 - 00606959012264

AF531 Mask with Entrainment Elbow, with CapStrap, Medium, USA
Respironics, Inc.
AF531 Mask EE with CapStrap, Medium, USA
Not in Commercial Distribution

  • 30606959012265 ()
  • 00606959012264 ()
1094803

  • CPAP/BPAP face mask, single-use

REMstar SE - 00606959037083

REMstar SE Auto with Humidifier, with SD Slot, Domestic
Respironics, Inc.
00
In Commercial Distribution

  • 00606959037083 ()
DS520HS

  • Home CPAP unit
  • Heated respiratory humidifier

REMstar SE - 00606959036925

REMstar SE with Heated Tube, with SD Slot, International
Respironics, Inc.
REMstar SE with Heated Tube, with SD Slot, INTL
In Commercial Distribution

  • 00606959036925 ()
IN221TS

  • Heated respiratory humidifier
  • Home CPAP unit

REMstar SE - 00606959036758

REMstar SE Auto with Humidifier, with SD Slot, Canada
Respironics, Inc.
REMstar SE Auto with Humidifier, with SD Slot, CA
In Commercial Distribution

  • 00606959036758 ()
CA521HS

  • Heated respiratory humidifier
  • Home CPAP unit

DreamStation - 00606959026667

DreamStation Auto BiPAP with Humidifier, with Heated Tube, Canada
Respironics, Inc.
DreamStation Auto BiPAP w/Humid, w/H Tube, CA
In Commercial Distribution

  • 00606959026667 ()
CAX700T12

  • Home BPAP unit

DreamStation - 00606959026636

DreamStation BiPAP Pro with Humidifier, with Heated Tube, Canada
Respironics, Inc.
DreamStation BiPAP Pro w/Humid w/H Tube, CA
In Commercial Distribution

  • 00606959026636 ()
CAX600T12

  • Home BPAP unit

DreamStation - 00606959026605

DreamStation Auto CPAP with Humidifier, with Heated Tube, Canada
Respironics, Inc.
DreamStation Auto CPAP w/Humid w/Heated Tube, CA
In Commercial Distribution

  • 00606959026605 ()
CAX500T12

  • Home CPAP unit

DreamStation - 00606959026575

DreamStation CPAP Pro with Humidifier, with Heated Tube, Canada
Respironics, Inc.
DreamStation CPAP Pro w/Humid w/Heated Tube, CA
In Commercial Distribution

  • 00606959026575 ()
CAX400T12

  • Home CPAP unit

DreamStation - 00606959026018

DreamStation Auto CPAP with Humidifier, with Heated Tube, Australia
Respironics, Inc.
DreamStation Auto CPAP w/Humid w/H Tube, AU
In Commercial Distribution

  • 00606959026018 ()
AUX500T15

  • Home CPAP unit
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