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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® - D0036620050001

Soothe-Guard® Adult Apron with Collar .35mm - Cool Grey
Dentsply International Inc.
662005000
In Commercial Distribution

  • D0036620050001 ()
662005000

  • Radiation shielding apron

SOOTHE-GUARD® - D0036619053001

Soothe-Guard® Adult Pano Cape .35mm - Light Blue
Dentsply International Inc.
661905300
In Commercial Distribution

  • D0036619053001 ()
661905300

  • Radiation shielding apron

SOOTHE-GUARD® - D0036619050001

Soothe-Guard® Adult Apron with Collar .35mm - Light Blue
Dentsply International Inc.
661905000
In Commercial Distribution

  • D0036619050001 ()
661905000

  • Radiation shielding apron

SOOTHE-GUARD® - D0036618053001

Soothe-Guard® Adult Pano Cape .35mm - Navy Blue
Dentsply International Inc.
661805300
In Commercial Distribution

  • D0036618053001 ()
661805300

  • Radiation shielding apron

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

DreamStation - 00606959025660

DreamStation BiPAP Pro with Humidifier and Cellular, USA
Respironics, Inc.
DreamStation BiPAP Pro with Humidifier, with Cell, US
In Commercial Distribution

  • 00606959025660 ()
DSX600H11C

  • Home BPAP unit

DreamStation - 00606959025516

DreamStation BiPAP Pro with Humidifier and Cellular Modem, American Home Patient (AHP)
Respironics, Inc.
DreamStation BiPAP Pro with Humidifier, with Cell, AHP
Not in Commercial Distribution

  • 00606959025516 ()
AHX600H11C

  • Home BPAP unit

REMstar SE - 00606959020078

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

  • 00606959020078 ()
CA221HS

  • Heated respiratory humidifier
  • Home CPAP unit

REMstar SE - 00606959020047

REMstar SE with Humidifier, with SD Slot, AH
Respironics, Inc.
REMstar SE with Humidifier, with SD Slot, AH
Not in Commercial Distribution

  • 00606959020047 ()
AH220HS

  • Home CPAP unit
  • Heated respiratory humidifier
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