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

  • 00606959025981 ()
AUX400T15

  • Home CPAP unit
DreamStation Auto BiPAP with Humidifier, with Heated Tube, International
Respironics, Inc.
DreamStation Auto BiPAP w/Humid, w/H Tube, INTL
In Commercial Distribution

  • 00606959025950 ()
INX700T15

  • Home BPAP unit
DreamStation BiPAP Pro with Humidifier, with Heated Tube, International
Respironics, Inc.
DreamStation BiPAP Pro w/Humidi w/H Tube, INTL
In Commercial Distribution

  • 00606959025929 ()
INX600T15

  • Home BPAP unit
DreamStation CPAP Pro with Humidifier, with Heated Tube, International
Respironics, Inc.
DreamStation CPAP Pro w/Humid w/H Tube, INTL
In Commercial Distribution

  • 00606959025868 ()
INX400T15

  • Home CPAP unit
FitLife Mask with Headgear, with Standard Elbow, Large, Japan
Respironics, Inc.
FitLife Mask with Headgear, w/SE, Large, Japan
Not in Commercial Distribution

  • 00606959023093 ()
1061714

  • CPAP/BPAP face mask, reusable
FitLife Mask with Headgear, with Standard Elbow, Small, Japan
Respironics, Inc.
FitLife Mask with Headgear, w/SE, Small, Japan
In Commercial Distribution

  • 00606959023086 ()
1061713

  • CPAP/BPAP face mask, reusable
FitLife Mask with Headgear, with Standard Elbow, Large, International
Respironics, Inc.
FitLife Mask with Headgear, w/SE, Large, INTL
In Commercial Distribution

  • 00606959023062 ()
1061712

  • CPAP/BPAP face mask, reusable
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