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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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AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Large
Respironics, Inc.
AF541 Mask EE, Leak 1 w/ CAPSTRAP, Large, US
In Commercial Distribution

  • 30606959024428 ()
  • 00606959024427 ()
1121064

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Medium
Respironics, Inc.
AF541 Mask EE, Leak 1 w/ CAPSTRAP, Medium, US
In Commercial Distribution

  • 30606959024411 ()
  • 00606959024410 ()
1121063

  • CPAP/BPAP face mask, single-use
AF541 Mask with Entrainment Elbow, Leak 1, with CAPSTRAP, Small
Respironics, Inc.
AF541 Mask EE, Leak 1 w/ CAPSTRAP, Small, US
In Commercial Distribution

  • 30606959024404 ()
  • 00606959024403 ()
1121062

  • CPAP/BPAP face mask, single-use
DreamStation Auto BiPAP with Humidifier, with Heated Tube, Latin America
Respironics, Inc.
DreamStation Auto BiPAP w/Humid, w/H Tube, LA
In Commercial Distribution

  • 00606959028593 ()
LAX700T15

  • Home BPAP unit
DreamStation BiPAP Pro with Humidifier, with Heated Tube, Latin America
Respironics, Inc.
DreamStation BiPAP Pro w/Humid w/H Tube, Latin America
In Commercial Distribution

  • 00606959028562 ()
LAX600T15

  • Home BPAP unit
DreamStation Auto CPAP with Humidifier, with Heated Tube, Latin America
Respironics, Inc.
DreamStation Auto CPAP w/Humidifier, w/H Tube, LA
In Commercial Distribution

  • 00606959028531 ()
LAX500T15

  • Home CPAP unit
DreamStation CPAP Pro with Humidifier, with Heated Tube, Latin America
Respironics, Inc.
DreamStation CPAP Pro w/Humid w/H Tube, LA
In Commercial Distribution

  • 00606959028500 ()
LAX400T15

  • Home CPAP unit
PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, LARGE, INTERNATIONAL
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, INT, LARGE
In Commercial Distribution

  • 30606959028440 ()
  • 00606959028449 ()
1126378

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, LARGE, JAPAN
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, JP, LARGE
Not in Commercial Distribution

  • 30606959028433 ()
  • 00606959028432 ()
1126377

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, MEDIUM, INTERNATIONAL
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, INT, MEDIUM
In Commercial Distribution

  • 30606959028426 ()
  • 00606959028425 ()
1126376

  • CPAP/BPAP face mask, single-use
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