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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

PERFORMATRAK - 00606959027701

Performatrak Mask with Standard Elbow, with Headgear, Dispossable, Medium, Korea
Respironics, Inc.
Performatrak SE Mask w/Headgear, Disp, MEDIUM, KR
Not in Commercial Distribution

  • 30606959027702 ()
  • 00606959027701 ()
1119725

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959027688

Performatrak Mask with Standard Elbow, with Headgear, Disposable, Large, Korea
Respironics, Inc.
Performatrak SE Mask w/Headgear, Disp, LARGE, KR
Not in Commercial Distribution

  • 30606959027689 ()
  • 00606959027688 ()
1119726

  • CPAP/BPAP face mask, single-use

DreamWear - 00606959026988

DreamWear Gel Pillows Mask with Medium Frame, with Headgear, International
Respironics, Inc.
DreamWear Gel Pillows Mask, Med Frame w/Headgr, INTL
In Commercial Distribution

  • 00606959026988 ()
1125024

  • CPAP/BPAP nasal mask, reusable
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