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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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SOOTHE-GUARD® - D0036618050001

Soothe-Guard® Adult Apron with Collar .35mm- Navy Blue
Dentsply International Inc.
661805000
In Commercial Distribution

  • D0036618050001 ()
661805000

  • Radiation shielding apron

SOOTHE-GUARD® - D0036618047001

Soothe-Guard® Child Apron with Collar .35mm - Navy Blue
Dentsply International Inc.
661804700
In Commercial Distribution

  • D0036618047001 ()
661804700

  • Radiation shielding apron

JOBST Elvarex - 04019702303100

Elvarex 2/Glove to elbow/With Finger, with Thumb/Slip form with volant
BSN-Jobst GmbH
77359-00007-00
In Commercial Distribution

  • 04019702303100 ()

  • Pressure: 23-32 mmHg


  • Compression/pressure sock/stocking, reusable

DreamStation BiPAP AVAPS - 00606959045774

DreamStation BiPAP AVAPS30 AE with Humdifier, with Heated Tube, with Cell Modem, Australia
Respironics, Inc.
DreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/Cell, AU
In Commercial Distribution

  • 00606959045774 ()
AUX1131T15C

  • Portable electric ventilator

AF541 - 00606959041370

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

  • 30606959041371 ()
  • 00606959041370 ()
1129506

  • CPAP/BPAP face mask, single-use

AF541 - 00606959041363

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

  • 30606959041364 ()
  • 00606959041363 ()
1129505

  • CPAP/BPAP face mask, single-use

DreamStation - 00606959034297

DreamStation BiPAP Pro with Humidifier and WiFi, American Home Patient
Respironics, Inc.
DreamStation BiPAP Pro with Humidifier, with WiFi, AHP
Not in Commercial Distribution

  • 00606959034297 ()
AHX600H11W

  • Home BPAP unit

REMstar SE - 00606959036918

REMstar SE with Humidifier, with SD Slot, International
Respironics, Inc.
REMstar SE with HUMIDIFIER, with SD Slot, INTL
In Commercial Distribution

  • 00606959036918 ()
IN221HS

  • Home CPAP unit
  • Heated respiratory humidifier

AF541 - 00606959024670

AF541 with Standard Elbow, with CapStrap, Extra Large
Respironics, Inc.
AF541 Mask with Standard Elbow, WITH CAPSTRAP, X-LARGE
In Commercial Distribution

  • 30606959024671 ()
  • 00606959024670 ()
1121081

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024656

AF541 Mask with Standard Elbow, with CapStrap, Medium
Respironics, Inc.
AF541 Mask with Standard Elbow, WITH CAPSTRAP, MEDIUM
In Commercial Distribution

  • 30606959024657 ()
  • 00606959024656 ()
1121079

  • CPAP/BPAP face mask, single-use
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