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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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REMstar SE - 00606959020085

REMstar SE with Heated Tube, with SD Slot, Canada
Respironics, Inc.
REMstar SE with Heated Tube, with SD Slot, CA
Not in Commercial Distribution

  • 00606959020085 ()
CA221TS

  • Heated respiratory humidifier
  • Home CPAP unit

REMstar SE - 00606959012509

REMstar SE with Heated Tube, with SD Slot, US
Respironics, Inc.
REMstar SE with Heated Tube, with SD Slot, US
Not in Commercial Distribution

  • 00606959012509 ()
DS220TS

  • Home CPAP unit
  • Heated respiratory humidifier

PERFORMATRAK - 00606959007567

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

  • 30606959007568 ()
  • 00606959007567 ()
1048719

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959007550

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

  • 30606959007551 ()
  • 00606959007550 ()
1048720

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959007543

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

  • 30606959007544 ()
  • 00606959007543 ()
1048721

  • CPAP/BPAP face mask, single-use

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

AF531 - 00606959012288

AF531 Mask with Standard Elbow, with CapStrap, Small, USA
Respironics, Inc.
AF531 Mask w/SE, with CapStrap, Small, USA
In Commercial Distribution

  • 30606959012289 ()
  • 00606959012288 ()
1094805

  • CPAP/BPAP face mask, single-use

AF531 - 00606959012264

AF531 Mask with Entrainment Elbow, with CapStrap, Medium, USA
Respironics, Inc.
AF531 Mask EE with CapStrap, Medium, USA
Not in Commercial Distribution

  • 30606959012265 ()
  • 00606959012264 ()
1094803

  • CPAP/BPAP face mask, single-use

AF531 - 00606959012257

AF531 Mask with Entrainment Elbow, with CapStrap, Small, USA
Respironics, Inc.
AF531 Mask EE with CapStrap, Small, USA
In Commercial Distribution

  • 30606959012258 ()
  • 00606959012257 ()
1094802

  • CPAP/BPAP face mask, single-use

Midmark Vantage Cephalometric Sensor - 00841709102585

Panoramic X-ray Assembly with Cephalometric Extension with no sensor
MIDMARK CORPORATION
60-A1019
In Commercial Distribution

  • 00841709102585 ()
60-A1019

  • Stationary cephalometric x-ray system, digital
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