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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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FITLIFE - 00606959023093

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 - 00606959023062

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

DreamStation - 00606959022515

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

  • 00606959022515 ()
DSX600T11

  • Home BPAP unit

DreamStation - 00606959022485

DreamStation Auto CPAP with Humidifier, with Heated Tube, USA
Respironics, Inc.
DreamStation Auto CPAP w/Humid w/Heated Tube, US
In Commercial Distribution

  • 00606959022485 ()
DSX500T11

  • Home CPAP unit

REMstar SE - 00606959020054

REMstar SE with Heated Tube, with SD Slot, AH
Respironics, Inc.
REMstar SE with Heated Tube, with SD Slot, AH
In Commercial Distribution

  • 00606959020054 ()
AH220TS

  • Heated respiratory humidifier
  • Home CPAP unit

REMstar System One 50 Series - 00606959001046

REMstar Auto A-Flex with Humidifier, with SD Card, China
Respironics, Inc.
REMstar Auto A-Flex with Humidifier, with SD Card, China
Not in Commercial Distribution

  • 00606959001046 ()
CN557HS

  • Home CPAP unit

Type-S™ Overlay - 00841439107119

with thermoplastic frame for use with Hitachi proton system
MEDTEC, INC.
MTPT210002
In Commercial Distribution

  • 00841439107119 ()
MTPT210002

  • Indexed-immobilization patient positioning system

IPPS™ Overlay - 00841439106839

53cm overlay with template for use with Philips Ingenia
MEDTEC, INC.
MTM3406
In Commercial Distribution

  • 00841439106839 ()
MTM3406

  • Indexed-immobilization patient positioning system

Universal Couchtop™ - 00841439105719

For use with Elekta X-Box base with Lok-Bar™
MEDTEC, INC.
MTIL624015
In Commercial Distribution

  • 00841439105719 ()
MTIL624015

  • Indexed-immobilization patient positioning system

Universal Couchtop™ - 00841439105467

For use with Siemens Definition MPT with Lok-Bar™
MEDTEC, INC.
MTIL604515
In Commercial Distribution

  • 00841439105467 ()
MTIL604515

  • Indexed-immobilization patient positioning system
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