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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 - 00606959028500

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 - 00606959028449

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 - 00606959028432

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 - 00606959028425

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

PERFORMATRAK - 00606959028418

PERFORMATRAK FULL MASK, WITH STANDARD ELBOW WITH CAPSTRAP, MEDIUM, JAPAN
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, JP, MEDIUM
Not in Commercial Distribution

  • 30606959028419 ()
  • 00606959028418 ()
1126375

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959028401

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

  • 30606959028402 ()
  • 00606959028401 ()
1126374

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959028395

PERFORMATRAK FULL MASK WITH STANDARD ELBOW WITH CAPSTRAP, SMALL, JAPAN
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, JPN, SMALL
Not in Commercial Distribution

  • 30606959028396 ()
  • 00606959028395 ()
1126373

  • CPAP/BPAP face mask, single-use

AF541 - 00606959041356

AF541 Mask with Standard Elbow, with Capstrap, Size Small, Japan
Respironics, Inc.
AF541 Mask with Standard Elbow, with Capstrap, Small, JP
Not in Commercial Distribution

  • 30606959041357 ()
  • 00606959041356 ()
1129504

  • CPAP/BPAP face mask, single-use

DreamStation - 00606959040922

DreamStation BiPAP AVAPS 30 with humidifier, with heated tubing, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 AAM w/Humid w/H Tube, CA
In Commercial Distribution

  • 00606959040922 ()
CAX1130T12

  • Portable electric ventilator

DreamStation - 00606959040892

DreamStation BiPAP AVAPS 30 with Humidifier, with Heated Tubing, USA
Respironics, Inc.
DreamStation BiPAP AVAPS30 w/Humid w/H Tube,US
In Commercial Distribution

  • 00606959040892 ()
DSX1130T11

  • Portable electric ventilator
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