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

  • 00606959038585 ()
CAV201H

  • Home CPAP unit
  • Heated respiratory humidifier
DreamStation WiFi with Oximetry, Canada
Respironics, Inc.
DreamStation Wi-Fi Accessory with Oximetry, CA
In Commercial Distribution

  • 00606959037533 ()
200710W

  • Medical networking interface unit
REMstar Pro, with BlueTooth, Canada
Respironics, Inc.
REMstar Pro w/BlueTooth, CA
In Commercial Distribution

  • 00606959030169 ()
461CABT

  • Home CPAP unit
REMStar Pro, with BlueTooth, USA
Respironics, Inc.
REMStar Pro, w/BlueTooth, US
In Commercial Distribution

  • 00606959030114 ()
460PBT

  • Home CPAP unit
Plain pediatric band with loop
Hangzhou DTC Medical Apparatus Co., Ltd.
B611
In Commercial Distribution

  • 06973554430255 ()


  • Orthodontic metal band
Endodontic Irrigation Syringe with Needle
Cardinal Health 200, LLC
8881513843
In Commercial Distribution

  • 50192253037850 ()
  • 20192253037859 ()
  • 10192253037852 ()
8881513843

  • Irrigation syringe
OPEN HEART WITH 003 PACK
Cardinal Health 200, LLC
SCV33OH444
In Commercial Distribution

  • 50197106518203 ()
  • 10197106518205 ()
SCV33OH444

  • Cardiothoracic surgical procedure kit, medicated, single-use
StatLock Pro DCK with BioPatch
Bard Access Systems, Inc.
M000005
In Commercial Distribution

  • 10801741148740 ()
  • 00801741148743 ()
M000005

  • Intravenous administration tubing extension set
StatLock Pro DCK with GuardIVa
Bard Access Systems, Inc.
M000004
In Commercial Distribution

  • 10801741148733 ()
  • 00801741148736 ()
M000004

  • Intravenous administration tubing extension set
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