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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F60 DL Ped Autoclav FS Kit F60 DL Ped Autoclav FS Kit (1pc)
FLIGHT MEDICAL INNOVATIONS LTD
V64-0048
In Commercial Distribution

  • 17290013641028 ()


  • Ventilator breathing circuit, single-use
F60 DL Autoclav Flow Sensor Kit(10pc)
FLIGHT MEDICAL INNOVATIONS LTD
V64-0034
In Commercial Distribution

  • 17290013641011 ()


  • Ventilator breathing circuit, single-use
F60 DL Autoclavable PC(10pc)
FLIGHT MEDICAL INNOVATIONS LTD
V64-0055
In Commercial Distribution

  • 17290013641004 ()


  • Ventilator breathing circuit, single-use
No Description
Zhuhai Shineway Biotech Co.,Ltd
SWSI-02
In Commercial Distribution

  • 16974900600091 ()
  • 26974900600104 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Zhuhai Shineway Biotech Co.,Ltd
SWM-02
In Commercial Distribution

  • 16974900600039 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Fluido® Compact Control Module
The Surgical Company International B.V.
Control Module
In Commercial Distribution

  • 18719867002421 ()
650100-US

  • Conduction blood/fluid warmer
Fluido® Compact Warming Module
The Surgical Company International B.V.
Warming Module
In Commercial Distribution

  • 18719867001561 ()
650200

  • Conduction blood/fluid warmer
This extension tube can be connected to breathing circuit independently or together with elbow connector when necessary.
Changsha Magill Medical Technology Co., Ltd.
EXT-1
Not in Commercial Distribution

  • 86974599110504 ()
  • 06974599110508 ()


  • Ventilator breathing circuit, single-use
Luna® Integrated Heated Humidifier
BMC Medical Co., Ltd.
H60
In Commercial Distribution

  • 16948538362041 ()
  • 06948538362044 ()


  • Heated respiratory humidifier
RESmart® Integrated Heated Humidifier for BPAP 25A
BMC Medical Co., Ltd.
BMC-50
In Commercial Distribution

  • 16948538362034 ()
  • 06948538362037 ()


  • Heated respiratory humidifier
RESmart® Integrated Heated Humidifier for Auto CPAP
BMC Medical Co., Ltd.
BMC-50
In Commercial Distribution

  • 16948538362027 ()
  • 06948538362020 ()


  • Heated respiratory humidifier
RESmart® Integrated Heated Humidifier for CPAP
BMC Medical Co., Ltd.
BMC-50
In Commercial Distribution

  • 16948538362010 ()
  • 06948538362013 ()


  • Heated respiratory humidifier
No Description
ICU MEDICAL, INC.
100/905/341-CH
In Commercial Distribution

  • 35019517160226 ()
  • 15019517160222 ()


  • Ventilator breathing circuit, single-use
No Description
ICU MEDICAL, INC.
100/905/340-CH
In Commercial Distribution

  • 35019517160219 ()
  • 15019517160215 ()


  • Ventilator breathing circuit, single-use
No Description
ICU MEDICAL, INC.
100/905/320-CH
In Commercial Distribution

  • 35019517159664 ()
  • 15019517159660 ()


  • Ventilator breathing circuit, single-use
No Description
ICU MEDICAL, INC.
100/905/302-CH
In Commercial Distribution

  • 35019517159640 ()
  • 15019517159646 ()


  • Ventilator breathing circuit, single-use
No Description
ICU MEDICAL, INC.
100/905/301-CH
In Commercial Distribution

  • 35019517159602 ()
  • 15019517159608 ()


  • Ventilator breathing circuit, single-use
No Description
ICU MEDICAL, INC.
100/905/300-CH
In Commercial Distribution

  • 35019517159121 ()
  • 15019517159127 ()


  • Ventilator breathing circuit, single-use
QinFlow Warrior Lite Blood and Fluid Warmer Base Unit (BU). The BU controls the performance of the system and the outflow fluid temperature. The BU contains firmware (SW) and electronics (HW), a LED panel display for user notifications.
QUALITY IN FLOW LTD
QIF-03
In Commercial Distribution

  • 07290016740103 ()
QIF03-BUA1000

  • Conduction blood/fluid warmer
QinFlow Warrior Extreme system kit - the QiF warmer is a portable, inline blood and fluid warmer system. The QiF Blood and Fluid Warmer is located between the fluid container (intravenous fluid, blood or blood product) and treated patient, outside of the patient’s body. The kit contains 2 batteries. The S/N of the kit is identical to the S/N of the Base Unit inside the kit.
QUALITY IN FLOW LTD
QIF-01-12
In Commercial Distribution

  • 07290016740097 ()
Q1220S1000U

  • Conduction blood/fluid warmer
QinFlow Warrior Extreme Blood and Fluid Warmer Base Unit (BU). The BU controls the performance of the system and the outflow fluid temperature. The BU contains firmware (SW) and electronics (HW), a graphic display and audio speaker for user notifications.
QUALITY IN FLOW LTD
QIF-01-12
In Commercial Distribution

  • 07290016740073 ()
QPORT1100U12

  • Conduction blood/fluid warmer
QinFlow Blood and Fluid Warmer QiF-01 Base Unit (BU). The BU controls the performance of the system and the outflow fluid temperature. The BU contains firmware (SW) and electronics (HW), a graphic display and audio speaker for user notifications.
QUALITY IN FLOW LTD
01
In Commercial Distribution

  • 07290016740011 ()
QPORT1100U

  • Conduction blood/fluid warmer
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4162-16
In Commercial Distribution

  • 06975318150126 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4084-8
In Commercial Distribution

  • 06975318150119 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4082-8
In Commercial Distribution

  • 06975318150102 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4044-4
In Commercial Distribution

  • 06975318150096 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4042-4
In Commercial Distribution

  • 06975318150089 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4164-16
In Commercial Distribution

  • 06975318150072 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4162-16
In Commercial Distribution

  • 06975318150065 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4084-8
In Commercial Distribution

  • 06975318150058 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4082-8
In Commercial Distribution

  • 06975318150041 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4044-4
In Commercial Distribution

  • 06975318150034 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4042-4
In Commercial Distribution

  • 06975318150027 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4164-16
In Commercial Distribution

  • 06975318150010 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
For qualitative, quantitative, or melting curve analysis of nucleic acid samples derived from research specimens. For research use only.
Sansure Biotech Inc.
96-well, 0.2 mL block
In Commercial Distribution

  • 06955792700864 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NeuMoDx™ 96 Molecular System
Neumodx Molecular, Inc.
500200
Not in Commercial Distribution

  • 00814278020000 ()
  • 10814278020724 ()

  • Width: 137.2 Centimeter
  • Height: 109.2 Centimeter
  • Depth: 109.2 Centimeter
500200

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NeuMoDx™ 288 Molecular System
Neumodx Molecular, Inc.
500100
Not in Commercial Distribution

  • 00814278020727 ()
  • 10814278020014 ()

  • Depth: 109.2 Centimeter
  • Width: 182.9 Centimeter
  • Height: 190.5 Centimeter
500100

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
ManaCold Water Circulating Therapy Device is used decrease pain, swelling, and muscle spasms after surgery or injury. ManaCold consists of a cold water circulating unit, a 9 quart cooling reservoir with a lid, 7 foot insulation tube and a cold therapy pad. The cold therapy pad is applied to a patients injured area, delivering cold therapy through the tubing and into the cold pad. Commonly used following knee surgery, shoulder surgery or back surgery ManaCold can be used and operated by a patient or healthcare provider in a home or clinical setting
Manamed, Inc.
ManaCold
Not in Commercial Distribution

  • 00850998008980 ()
MANACOLD01

  • Circulating-fluid localized thermal therapy system
DeVilbiss IntelliPAP AutoBilevel w/heated humid, heated tube & SmartLink
Drive Devilbiss Healthcare
DV57D-HH-S-HT
Not in Commercial Distribution

  • 00885304008798 ()


  • Heated respiratory humidifier
No Description
VADI MEDICAL TECHNOLOGY CO., LTD.
9014-08
In Commercial Distribution

  • 14719894386390 ()
  • 04719894386393 ()
9014-08-510K1

  • Ventilator breathing circuit, single-use
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