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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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Salter AIRE Elite - 00607411007873

Compressor with Nebulizer (1) 8900
SALTER LABS
SO-1773BE
In Commercial Distribution

  • 00607411007873 ()
SO-1773BE

  • Benchtop nebulizer, non-heated

BOVIE - 00607151710118

REPLACEABLE FINE TIP WITH ADHESIVE
BOVIE MEDICAL CORPORATION
H101-ADH
In Commercial Distribution

  • 10607151710115 ()
  • 00607151710118 ()
H101-ADH

  • Open-surgery electrosurgical electrode, monopolar, single-use

Bovie - 00607151563172

DISPOSABLE ELECTROSURGICAL PENCIL WITH HOLSTER
BOVIE MEDICAL CORPORATION
ESP1H
In Commercial Distribution

  • 10607151563179 ()
  • 00607151563172 ()
ESP1H

  • Electrosurgical handpiece, single-use

DreamStation - 00606959043299

DreamStation CPAP with Humidifier, Korea
Respironics, Inc.
DreamStation CPAP with Humidifier, KR
Not in Commercial Distribution

  • 00606959043299 ()
KRX200H15

  • Home CPAP unit

REMstar System One 60 Series - 00606959042858

REMstar Auto, with Bluetooth, USA
Respironics, Inc.
REMStar Auto w/BlueTooth, US
In Commercial Distribution

  • 00606959042858 ()
560PBT

  • Home CPAP unit

DreamStation - 00606959042124

DreamStation CPAP with Humidifier, China
Respironics, Inc.
DreamStation CPAP with Humidifier, CN
Not in Commercial Distribution

  • 00606959042124 ()
CNX200H17

  • Home CPAP unit

Dorma - 00606959038608

Dorma 200 with Humidifier, China
Respironics, Inc.
Dorma 200, with Humidifier, CN
Not in Commercial Distribution

  • 00606959038608 ()
CNV207H

  • Heated respiratory humidifier
  • Home CPAP unit

Dorma - 00606959038585

Dorma 200 with Humidifier, Canada
Respironics, Inc.
Dorma 200 with Humidifier, CA
In Commercial Distribution

  • 00606959038585 ()
CAV201H

  • Home CPAP unit
  • Heated respiratory humidifier

DreamStation - 00606959037533

DreamStation WiFi with Oximetry, Canada
Respironics, Inc.
DreamStation Wi-Fi Accessory with Oximetry, CA
In Commercial Distribution

  • 00606959037533 ()
200710W

  • Medical networking interface unit

Dorma - 00606959037045

Dorma 200 with Humidifier, LD
Respironics, Inc.
Dorma 200, with Humidifier, LD
In Commercial Distribution

  • 00606959037045 ()
LDV201H

  • Heated respiratory humidifier
  • Home CPAP unit
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