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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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DreamStation - 00606959040533

DreamStation BiPAP autoSV with Humidifier, with Heated Tube, USA
Respironics, Inc.
DreamStation BiPAP autoSV w/Humidr w/H Tube, US
In Commercial Distribution

  • 00606959040533 ()
DSX900T11

  • Portable electric ventilator

PERFORMATRAK - 00606959007550

PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, MEDIUM
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, MEDIUM
In Commercial Distribution

  • 30606959007551 ()
  • 00606959007550 ()
1048720

  • CPAP/BPAP face mask, single-use

AF531 - 00606959012295

AF531 Mask with Standard Elbow, with CapStrap, Medium, USA
Respironics, Inc.
AF531 Mask w/SE, with CapStrap, Medium, USA
In Commercial Distribution

  • 30606959012296 ()
  • 00606959012295 ()
1094806

  • CPAP/BPAP face mask, single-use

AF531 - 00606959012288

AF531 Mask with Standard Elbow, with CapStrap, Small, USA
Respironics, Inc.
AF531 Mask w/SE, with CapStrap, Small, USA
In Commercial Distribution

  • 30606959012289 ()
  • 00606959012288 ()
1094805

  • CPAP/BPAP face mask, single-use

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
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