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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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DAR - 20884521056340

Adult Breathing Circuit with Exhalation Valve
Covidien LP
5093600
In Commercial Distribution

  • 10884521056343 ()
  • 20884521056340 ()


  • Ventilator breathing circuit, single-use

Puritan Bennett - 20884521706986

Disposable Adult Circuit
Covidien LP
Y-6463
In Commercial Distribution

  • 10884521706989 ()
  • 20884521706986 ()


  • Ventilator breathing circuit, single-use

Puritan Bennett - 20884521706979

Disposable Pediatric Circuit
Covidien LP
Y-6464
In Commercial Distribution

  • 10884521706972 ()
  • 20884521706979 ()


  • Ventilator breathing circuit, single-use

DAR - 20884521083568

Adult Breathing Circuit with Exhalation Valve,Pressure Monitoring Line
Covidien LP
5094000
In Commercial Distribution

  • 10884521083561 ()
  • 20884521083568 ()


  • Ventilator breathing circuit, single-use

buddy 2 SYSTEM - 20896128002828

BUDDY 2 SYSTEM, FRENCH
BELMONT INSTRUMENT CORPORATION
905-00037-F
Not in Commercial Distribution

  • 20896128002828 ()


  • Conduction blood/fluid warmer

BUDDY LITER WITH AC, BATTERY HOUSING AND HEATER UNIT, EUROPEAN - 20896128002545

BUDDY LITER, BATTERY HOUSING AND HEATER UNIT, EUROPEAN, CHARGER
BELMONT INSTRUMENT CORPORATION
905-00034
Not in Commercial Distribution

  • 20896128002545 ()


  • Conduction blood/fluid warmer

buddy lite® Blood/Fluid Warmer - 20896128002491

No Description
BELMONT INSTRUMENT CORPORATION
905-00017
In Commercial Distribution

  • 20896128002491 ()


  • Conduction blood/fluid warmer

BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, EUROPEAN - 20896128002446

ASSY, BUDDY LITE WITH AC, BATTERY HOUSING AND HEATER UNIT, EUROPEAN, CHARGER
BELMONT INSTRUMENT CORPORATION
905-00023
Not in Commercial Distribution

  • 20896128002446 ()


  • Conduction blood/fluid warmer

3100B HFOV - 20846446003663

ASSY, 3100B FILTERED PAT CKT, FP850, BOXED
Carefusion Corporation
16390-102
Not in Commercial Distribution

  • 20846446003663 ()
  • 00846446003669 ()
16390-102

  • Ventilator breathing circuit, single-use

3100B HFOV - 20846446003656

ASSY, 3100B FILTERED PAT CKT, FP730, BOXED
Carefusion Corporation
16390-101
Not in Commercial Distribution

  • 20846446003656 ()
  • 00846446003652 ()
16390-101

  • Ventilator breathing circuit, single-use

3100B HFOV - 20846446003649

ASSY, 3100B FILTERED PAT CKT, HRCI, BOXED
Carefusion Corporation
16390-103
Not in Commercial Distribution

  • 20846446003649 ()
  • 00846446003645 ()
16390-103

  • Ventilator breathing circuit, single-use

3100A HFOV - 20846446003397

SHORT PAT CKT, F&P850, BOX 4, 31A
Carefusion Corporation
773996
Not in Commercial Distribution

  • 20846446003397 ()
  • 00846446003393 ()
773996

  • Ventilator breathing circuit, single-use

3100A HFOV - 20846446003380

FLEX CKT 38IN HTD WIRE F&P 730 BX 4
Carefusion Corporation
771374
Not in Commercial Distribution

  • 20846446003380 ()
  • 00846446003386 ()
771374

  • Ventilator breathing circuit, single-use

3100A HFOV - 20846446003373

LONG PAT CKT, F&P850, BOX 4, 31A
Carefusion Corporation
773997
Not in Commercial Distribution

  • 20846446003373 ()
  • 00846446003379 ()
773997

  • Ventilator breathing circuit, single-use

3100A HFOV - 20846446003366

FLEX CKT 51IN HTD WIRE F&P 730 BX 4
Carefusion Corporation
771375
Not in Commercial Distribution

  • 20846446003366 ()
  • 00846446003362 ()
771375

  • Ventilator breathing circuit, single-use

3100A HFOV - 20846446003359

CKT W/SHRT HTD WIRE 380-88 & 400 BX4
Carefusion Corporation
771465
Not in Commercial Distribution

  • 20846446003359 ()
  • 00846446003355 ()
771465

  • Ventilator breathing circuit, single-use

3100A HFOV - 20846446003304

CKT W/SHORT HTD WIRE 380-90 BX4
Carefusion Corporation
771463
Not in Commercial Distribution

  • 20846446003304 ()
  • 00846446003300 ()
771463

  • Ventilator breathing circuit, single-use

3100A HFOV - 20846446003298

CKT W/LG HTD WIRE 380-88 RCI BX4
Carefusion Corporation
771466
Not in Commercial Distribution

  • 20846446003298 ()
  • 00846446003294 ()
771466

  • Ventilator breathing circuit, single-use

O-Two - 07540195005211

The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve or gas mixers to deliver oxygen or nitrous oxide and oxygen mixture gas to patients. It consists of one corrugated breathing hose, an inspiratory one-way valve, and a PEEP port. The 01CV8019 with anti-entrainment flapper and facemask/mouth piece is specifically designed for use with O-Two Equinox Relieve and Equinox Advantage nitrous oxide and oxygen gas mixing and delivery units.
O-Two Medical Technologies Inc
01CV8019
In Commercial Distribution

  • 17540195005218 ()
  • 07540195005211 ()

  • Weight: 80 Gram
  • Length: 40 Inch
01CV8019-CS

  • Ventilator breathing circuit, single-use

O-Two - 07540195005181

The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve or gas mixers to deliver oxygen or nitrous oxide and oxygen mixture gas to patients. It consists of one corrugated breathing hose, an inspiratory one-way valve, and a PEEP port. The 01CV8016 is specifically designed for use with CAREvent MRI ventilators and is long enough to allow free passage of the patient in and out of the MRI unit without the risk of pulling on the tubing.
O-Two Medical Technologies Inc
01CV8016
In Commercial Distribution

  • 17540195005188 ()
  • 07540195005181 ()

  • Length: 10 Feet
01CV8016-CS

  • Ventilator breathing circuit, single-use

O-Two - 07540195005174

The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve or gas mixers to deliver oxygen or nitrous oxide and oxygen mixture gas to patients. It consists of one corrugated breathing hose, an inspiratory one-way valve, and a PEEP port. The 01CV8015 with anti-entrainment flapper is specifically designed for use on O-Two automatic resuscitators and transport ventilators and other ventilators that respond to the spontaneous breathing.
O-Two Medical Technologies Inc
01CV8015
In Commercial Distribution

  • 17540195005171 ()
  • 07540195005174 ()

  • Length: 40 Inch
  • Weight: 80 Gram
01CV8015-CS

  • Ventilator breathing circuit, single-use

O-Two - 07540195005129

The O-Two single-use ventilation circuit is designed to be used with ventilators, demand valve or gas mixers to deliver oxygen or nitrous oxide and oxygen mixture gas to patients. It consists of one corrugated breathing hose, an inspiratory one-way valve. The 01CV8010 is specifically designed for use on Bag-Valve-Mask resuscitators and ventilators without demand breathing or patient triggered ventilation modes.
O-Two Medical Technologies Inc
01CV8010
In Commercial Distribution

  • 07540195005129 ()
  • 17540195005126 ()

  • Weight: 80 Gram
  • Length: 40 Inch
01CV8010-CS

  • Ventilator breathing circuit, single-use

HUDSON RCI - 24026704594836

Venti-Comp
TELEFLEX INCORPORATED
IPN042593
In Commercial Distribution

  • 24026704594836 ()
  • 14026704594839 ()
1550

  • Ventilator breathing circuit, single-use

HUDSON RCI - 24026704658880

TUBING ASSY,FILTER,VENT MAIN LINE
TELEFLEX INCORPORATED
IPN913683
In Commercial Distribution

  • 14026704658883 ()
  • 24026704658880 ()
1606

  • Ventilator breathing circuit, single-use

HUDSON RCI - 24026704656701

Venti-Comp
TELEFLEX INCORPORATED
IPN913925
In Commercial Distribution

  • 24026704656701 ()
  • 14026704656704 ()
  • 24026704594836 ()
1550

  • Ventilator breathing circuit, single-use

QinFlow Warrior Lite set with 2 Lite Extra Power Battery - 27290016740169

QinFlow Warrior Lite system kit with Lite Extra Power Battery - 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 Lite Extra Power 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-03
In Commercial Distribution

  • 27290016740169 ()


  • Conduction blood/fluid warmer

QIF-01 extended kit - 27290016740039

QinFlow Warrior 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
01
In Commercial Distribution

  • 27290016740039 ()
Q1120S1000U

  • Conduction blood/fluid warmer

QINFLOW WARRIOR HYBRID EXTENDED SET - 27290016740046

QinFlow Warrior/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 and AC Power supply. The S/N of the kit is identical to the S/N of the Base Unit inside the kit.
QUALITY IN FLOW LTD
01
In Commercial Distribution

  • 27290016740046 ()


  • Conduction blood/fluid warmer

Fluido® Compact - 18719867002421

Fluido® Compact Control Module
The Surgical Company International B.V.
Control Module
In Commercial Distribution

  • 18719867002421 ()
650100-US

  • Conduction blood/fluid warmer

Fluido® Compact - 18719867001561

Fluido® Compact Warming Module
The Surgical Company International B.V.
Warming Module
In Commercial Distribution

  • 18719867001561 ()
650200

  • Conduction blood/fluid warmer

ClosureFast™ - 00763000702298

CATHETER CF7-3-60 CLOSURE FAST V05
MEDTRONIC, INC.
CF7-3-60
In Commercial Distribution

  • 00763000702298 ()

  • Introducer sheath: 7 Fr
  • Length: 3.0 Centimeter
  • Length: 60.0 Centimeter


  • Peripheral vascular electrocautery catheter, single-use

ClosureFast™ - 00763000702281

CATHETER CF7-7-60 CLOSURE FAST V05
MEDTRONIC, INC.
CF7-7-60
In Commercial Distribution

  • 00763000702281 ()

  • Length: 7.0 Centimeter
  • Length: 60.0 Centimeter
  • Introducer sheath: 7 Fr


  • Peripheral vascular electrocautery catheter, single-use

ClosureFast™ - 00763000702274

CATHETER CF7-7-100 CLOSURE FAST V05
MEDTRONIC, INC.
CF7-7-100
In Commercial Distribution

  • 00763000702274 ()

  • Length: 7.0 Centimeter
  • Introducer sheath: 7 Fr
  • Length: 100.0 Centimeter


  • Peripheral vascular electrocautery catheter, single-use

Luna® - 06948538362044

Luna® Integrated Heated Humidifier
BMC Medical Co., Ltd.
H60
In Commercial Distribution

  • 16948538362041 ()
  • 06948538362044 ()


  • Heated respiratory humidifier

RESmart® Integrated Heated Humidifier for BPAP 25A - 06948538362037

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 - 06948538362020

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 - 06948538362013

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

  • 16948538362010 ()
  • 06948538362013 ()


  • Heated respiratory humidifier

DeVilbiss - 00885304008798

DeVilbiss IntelliPAP AutoBilevel w/heated humid, heated tube & SmartLink
Drive Devilbiss Healthcare
DV57D-HH-S-HT
Not in Commercial Distribution

  • 00885304008798 ()


  • Heated respiratory humidifier

Pneupac - 15019517160222

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

  • 35019517160226 ()
  • 15019517160222 ()


  • Ventilator breathing circuit, single-use

Pneupac - 15019517160215

No Description
ICU MEDICAL, INC.
100/905/340-CH
In Commercial Distribution

  • 35019517160219 ()
  • 15019517160215 ()


  • Ventilator breathing circuit, single-use

Pneupac - 15019517159660

No Description
ICU MEDICAL, INC.
100/905/320-CH
In Commercial Distribution

  • 35019517159664 ()
  • 15019517159660 ()


  • Ventilator breathing circuit, single-use

Pneupac - 15019517159646

No Description
ICU MEDICAL, INC.
100/905/302-CH
In Commercial Distribution

  • 35019517159640 ()
  • 15019517159646 ()


  • Ventilator breathing circuit, single-use

Pneupac - 15019517159608

No Description
ICU MEDICAL, INC.
100/905/301-CH
In Commercial Distribution

  • 35019517159602 ()
  • 15019517159608 ()


  • Ventilator breathing circuit, single-use

Pneupac - 15019517159127

No Description
ICU MEDICAL, INC.
100/905/300-CH
In Commercial Distribution

  • 35019517159121 ()
  • 15019517159127 ()


  • Ventilator breathing circuit, single-use

Patient Circuit - 17290013641875

F60 SL Ped. Autoclav FS Kit
FLIGHT MEDICAL INNOVATIONS LTD
V64-0047
In Commercial Distribution

  • 17290013641875 ()


  • Ventilator breathing circuit, single-use

Patient Circuit - 17290013641806

F60 SL Autoclavable PC
FLIGHT MEDICAL INNOVATIONS LTD
V64-0054
In Commercial Distribution

  • 17290013641806 ()


  • Ventilator breathing circuit, single-use

Patient Circuit - 17290013641707

F60 Ped DL Flow Sensor Kit RD
FLIGHT MEDICAL INNOVATIONS LTD
V64-0058
In Commercial Distribution

  • 17290013641707 ()


  • Ventilator breathing circuit, single-use

QinFlow Warrior Lite set with 1 Lite Extra Power Battery - 17290016740162

QinFlow Warrior Lite system kit with Lite Extra Power Battery - 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 1 Lite Extra Power battery. The S/N of the kit is identical to the S/N of the Base Unit inside the kit.
QUALITY IN FLOW LTD
QIF-03
In Commercial Distribution

  • 17290016740162 ()


  • Conduction blood/fluid warmer

QINFLOW WARRIOR HYBRID INTRO SET - 17290016740049

QINFLOW WARRIOR HYBRID INTRO SET - 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 1 battery and AC Power supply module. The S/N of the kit is identical to the S/N of the Base Unit inside the kit.
QUALITY IN FLOW LTD
01
In Commercial Distribution

  • 17290016740049 ()


  • Conduction blood/fluid warmer

Patient Circuit - 17290013641998

F60 SL ped. Flow Sensor Kit
FLIGHT MEDICAL INNOVATIONS LTD
V64-0052
In Commercial Distribution

  • 17290013641998 ()


  • Ventilator breathing circuit, single-use
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