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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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Life Warmer Quantum Blood and Fluid Warming System - 00868058000485

The Lifewarmer Quantum Blood and Fluid Warming System is a Game-Changing innovation that has succeeded in closing a critical capability gap previously left exposed by other commercial off-the-shelf fluid warmers currently fielded. Size, weight, performance, and ease of use are no longer collective barriers to the delivery of whole blood in far forward and near point of injury (POI) prehospital casualty management. The Quantum exceeds all healthcare and logistical requirements for the delivery of warmed blood or fluids across the defined spectrum of care. The system consists of unique thermal administration sets that incorporate sensing elements with an integrated heating system that does not disrupt the fluid path. With advanced intelligence throughout the system, the lightweight Controller modulates and moderates the energy flow to the integrated heating elements to ensure consistent normothermic fluid delivery to the casualty. The 44V battery is the smallest in category, able to rapidly adjust power distribution based on the temperature and flow rate of the input fluid. This creates a highly efficient system capable of previously unrealized performance optimizations. The Quantum system has an operational weight of just 22 total ounces yet can deliver two units of 39°F Whole Blood (WB) at 100mL/min with an output temperature of 100.4°F (38°+/- 2°C) with only a 24 second warm-up period. The Quantum Blood and Fluid Warming System provides the Tactical Health Care Professional with significant technological overmatch in the fight to eliminate preventable combat death. Quantum System Contents: 1 x Controller 1 x Battery 1 x Battery Charger 2 x TTS-B (Thermal Transfusion Set - Blood) NOTE: TTS-B is Single Use Only, Supplied sterile via Ethylene Oxide
NORTH AMERICAN RESCUE, LLC
63-5900
In Commercial Distribution

  • 00868058000485 ()
35-0006

  • Conduction blood/fluid warmer

Life Warmer Quantum Charger - 00868058000430

The Lifewarmer Quantum Charger from is an AC-powered reusable device that can fully charge the Quantum Battery rapidly and safely. The Charger has built-in algorithms to ensure proper, steady charging without overcharging or damaging the health and integrity of the battery. The Battery can go from nearly 0% to full within 90 minutes. The Life Warmer Charger has two colored LED lights to inform the provider of the status of charge and condition of the battery. The Quantum Battery Charger connects to the Battery via an omni-directional plug that allows for rapid energy transfer while prioritizing safety even in cases of hasty disconnection. The Quantum Battery will alert the user if there is any issue associated with the health of the battery. The Charger comes supplied with a 6-foot AC power cord.
NORTH AMERICAN RESCUE, LLC
63-5905
In Commercial Distribution

  • 00868058000430 ()
35-0002

  • Conduction blood/fluid warmer

Heated CPAP Tube - 00848530090609

HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER)
SUNSET HEALTHCARE SOLUTIONS, INC.
TUB06HPR
In Commercial Distribution

  • 10848530090606 ()
  • 00848530090609 ()


  • Heated respiratory humidifier

Heated CPAP Tube for DreamStation Series and PR System One - 00848530070670

Heated CPAP Tube for DreamStation Series and PR System One- 6ft Light Gray Smoothbore CPAP Tubing - Slim Style
SUNSET HEALTHCARE SOLUTIONS, INC.
TUB006SSRP
In Commercial Distribution

  • 00848530070670 ()


  • Heated respiratory humidifier

Passive Heated Breathing Circuit Kit - 00848530104153

(1) Adult Single Limb Passive Heated Wire Circuit - Fisher & Paykel OEM # RT114 with (1) Swivel Exhalation Port for Ventilator Circuits & CPAP (Comparable to Respironics 332113)
SUNSET HEALTHCARE SOLUTIONS, INC.
VC1114-KIT
In Commercial Distribution

  • 00848530104153 ()


  • Heated respiratory humidifier

Sunset Heated CPAP Tube - 00848530102753

HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER)
SUNSET HEALTHCARE SOLUTIONS, INC.
TUB06HPR-E
In Commercial Distribution

  • 00848530102753 ()
TUB06HPR-E

  • Heated respiratory humidifier

NeoPod T, Neonatal Transport Humidification System - 00850018561648

Neonatal Transport Humidification System
INTERNATIONAL BIOMEDICAL, LTD.
9400
In Commercial Distribution

  • 00850018561648 ()
9400

  • Heated respiratory humidifier

AirLife™ - 10889483573389

AirLife™ Isothermal™ Breathing Circuit Infant Respiratory Circuit Non-Heated
AIRLIFE
1209-503
In Commercial Distribution

  • 30889483573383 ()
  • 10889483573389 ()

  • Length: 4 Feet
1209-503

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483573372

Isothermal Breathing Circuit 1.3 m (4.5’) • Pediatric Respiratory Circuit Non-Heated
AIRLIFE
1206-701
In Commercial Distribution

  • 30889483573376 ()
  • 10889483573372 ()
  • 10190752157514 ()
1206-701

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572993

Isothermal™ Breathing Circuit Pediatric Respiratory Circuit Non heated
AIRLIFE
10828-701
In Commercial Distribution

  • 30889483572997 ()
  • 10889483572993 ()
  • 10190752156937 ()
10828-701

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572900

AirLife™ Breathing Circuit Pediatric Respiratory Circuit Heated
AIRLIFE
10794-H12
In Commercial Distribution

  • 30889483572904 ()
  • 10889483572900 ()
10794-H12

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572870

Isothermal™ Adult Respiratory Breathing Circuit Non-heated
AIRLIFE
10746-855
In Commercial Distribution

  • 30889483572874 ()
  • 10889483572870 ()
  • 10190752156920 ()
10746-855

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572825

Isothermal Pediatric Respiratory Breathing Circuit Non-heated
AIRLIFE
10608-701
In Commercial Distribution

  • 30889483572829 ()
  • 10889483572825 ()
  • 10190752151802 ()
10608-701

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572818

Isothermal™ Breathing Circuit Adult Respiratory Circuit Non–heated
AIRLIFE
10604-855
In Commercial Distribution

  • 30889483572812 ()
  • 10889483572818 ()
  • 10190752154513 ()
10604-855

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572689

Isothermal™ Breathing Circuit Accessory
AIRLIFE
10471-504
In Commercial Distribution

  • 30889483572683 ()
  • 10889483572689 ()
  • 10190752151833 ()
10471-504

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572672

Isothermal Breathing Circuit Pediatric Inspiratory Line Heated
AIRLIFE
10333-504
In Commercial Distribution

  • 30889483572676 ()
  • 10889483572672 ()
  • 10190752156777 ()
10333-504

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572658

AirLife™ Isothermal Breathing Circuit Accessory - 15mm Inspiratory Line Extension Special Product Request 15 - mm Inspiratory Line Extension
AIRLIFE
10303N-504
In Commercial Distribution

  • 30889483572652 ()
  • 10889483572658 ()
10303N-504

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572610

Isothermal™ Breathing Circuit Adult Respiratory Circuit Non–heated
AIRLIFE
10281-855
In Commercial Distribution

  • 30889483572614 ()
  • 10889483572610 ()
  • 10190752156753 ()
10281-855

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572559

Isothermal Breathing Circuit Accessory - 10mm Inspiratory line Extension
AIRLIFE
10225-504
In Commercial Distribution

  • 30889483572553 ()
  • 10889483572559 ()
  • 10190752158412 ()
10225-504

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572528

Isothermal Breathing Circuit Accessory
AIRLIFE
10155N-504
In Commercial Distribution

  • 30889483572522 ()
  • 10889483572528 ()
  • 10190752151857 ()
10155N-504

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572283

Isothermal Breathing Circuit Adult Inspiratory Line Heated
AIRLIFE
1006-H05
In Commercial Distribution

  • 30889483572287 ()
  • 10889483572283 ()
  • 10190752156746 ()
1006-H05

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572160

AirLife™ Ventilator Circuit With Exhalation Valve For use with ventilators that do not have internal exhalation valves
AIRLIFE
0Y3770
In Commercial Distribution

  • 30889483572164 ()
  • 10889483572160 ()
0Y3770

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572153

AirLife™ Ventilator Circuit 2.0 m (6.5') With (3 mm) 1/8" and (6 mm) 1/4" Pressure Lines For use with ventilators that have internal exhalation valves.
AIRLIFE
0Y1779
In Commercial Distribution

  • 30889483572157 ()
  • 10889483572153 ()
  • 10190752144811 ()
0Y1779

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572139

AirLife™ Ventilator Circuit 2.0 m (6.5') With (3 mm) 1/8" and (6 mm) 1/4" Pressure Lines and Valve Tee. For use with ventilators that have internal exhalation vales.
AIRLIFE
0Y1777
In Commercial Distribution

  • 30889483572133 ()
  • 10889483572139 ()
  • 10190752144804 ()
0Y1777

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572122

AirLife™ Ventilator Circuit With Parallel Patient "Y" and 1/8" and 1/4" Pressure Lines For use with ventilators that have internal exhalation valves
AIRLIFE
0P1776
In Commercial Distribution

  • 30889483572126 ()
  • 10889483572122 ()
0P1776

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483572115

AirLife™ Ventilator Circuit With Parallel Patient "Y" For use with ventilatiors that have internal exhalation valves
AIRLIFE
0P1775
In Commercial Distribution

  • 30889483572119 ()
  • 10889483572115 ()
0P1775

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483571972

Isothermal™ Breathing Circuit Infant Respiratory Circuit
AIRLIFE
0260-503
In Commercial Distribution

  • 30889483571976 ()
  • 10889483571972 ()
  • 10190752156722 ()
0260-503

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483571880

AirLife™ Exhalation Valve One Arm 22 mm I.D., One Arm 22 mm O.D., Closed Stern, Holding Arm and 22 mm O.D. Plug
AIRLIFE
004379
In Commercial Distribution

  • 30889483571884 ()
  • 10889483571880 ()
  • 10190752144736 ()
004379

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483571705

AirLife™ Smooth Bore Breathing Circuit
AIRLIFE
003769
In Commercial Distribution

  • 30889483571709 ()
  • 10889483571705 ()
003769

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483571699

AirLife™ Universal Portable Volume Ventilator Circuit With Exhalation Valve For use with ventilators that do not have internal exhalation valves
AIRLIFE
003764
In Commercial Distribution

  • 30889483571693 ()
  • 10889483571699 ()
003764

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483571682

AirLife™ Ventilator Circuit For LifeCare™ PLV-100 and PLV-102 Ventilators
AIRLIFE
003762
In Commercial Distribution

  • 30889483571686 ()
  • 10889483571682 ()
003762

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483571675

AirLife™ Ventilator Circuit For Aequitron Ventilators
AIRLIFE
003760
In Commercial Distribution

  • 30889483571679 ()
  • 10889483571675 ()
003760

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483570777

AirLife™ Ventilator Circuit Water Trap For Use with 22 mm Tubing
AIRLIFE
001860
In Commercial Distribution

  • 30889483570771 ()
  • 10889483570777 ()
  • 10190752144781 ()
001860

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483570555

AirLife™ Volume Ventilator Circuit For Portable Ventilator Machines Compatible with Puritan Bennett 2800 and Life Products LP-3
AIRLIFE
001797
In Commercial Distribution

  • 30889483570559 ()
  • 10889483570555 ()
001797

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483570548

AirLife™ Volume Ventilator Circuit 1.6 m (5') For Portable Ventilator Machines. Compatible with Life Products LP-4, LP-5*, LP-6, Lifecare PLV-100**, PLV-102, Aequitron LP-6, LP-6 Plus and LP-10
AIRLIFE
001795
In Commercial Distribution

  • 30889483570542 ()
  • 10889483570548 ()
  • 10190752144729 ()
001795

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483570531

AirLife™ Volume Ventilator Circuit For Use with Bear,* 1000, and Any Volume Ventilators Requiring 1/4" Pressure-Sensing Line
AIRLIFE
001794
In Commercial Distribution

  • 30889483570535 ()
  • 10889483570531 ()
  • 10190752144712 ()
001794

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483570524

AirLife™ Volume Ventilator Circuit For Use with Puritan-Bennett 7200A Volume Ventilators
AIRLIFE
001793
In Commercial Distribution

  • 30889483570528 ()
  • 10889483570524 ()
  • 10190752144767 ()
001793

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483570517

AirLife™ Volume Ventilator Circuit For Use with Siemens' Servo Ventilator and Puritan-Bennett 7200a2
AIRLIFE
001790
In Commercial Distribution

  • 30889483570511 ()
  • 10889483570517 ()
001790

  • Ventilator breathing circuit, single-use

AirLife™ - 10889483569375

AirLife™ Aerosol "Blow-By" Circuit Contains: Trach Tee with 5' (1.5 m) corrugated tubing on one limb and 6" (15 cm) corrugated tubing on other limb.
AIRLIFE
001218
In Commercial Distribution

  • 30889483569379 ()
  • 10889483569375 ()
  • 10190752145917 ()
001218

  • Ventilator breathing circuit, single-use

NeoGen - 05060440520334

Grey trolley (new logo)
ENERGIST LIMITED
SPA Grey Trolley
In Commercial Distribution

  • 05060440520334 ()
930-023

  • Nitrogen plasma skin surface treatment system

Neogen - 05060440520280

Neogen Trolley Complete Gry
ENERGIST LIMITED
Trolley Gry
In Commercial Distribution

  • 05060440520280 ()
930-020

  • Nitrogen plasma skin surface treatment system

Neogen - 05060440520273

Neogen Trolley Complete Blk
ENERGIST LIMITED
Trolley Blk
In Commercial Distribution

  • 05060440520273 ()
930-002

  • Nitrogen plasma skin surface treatment system

NeoGen - 05060440520266

NeoGen 25mm 3x Nozzle (Grey)
ENERGIST LIMITED
NeoGen 25mm 3x Nozzle (Grey)
In Commercial Distribution

  • 15060440520263 ()
  • 05060440520266 ()
830-060

  • Nitrogen plasma skin surface treatment system

NeoGen - 05060440520259

NeoGen 5mm 3x Nozzle (Grey)
ENERGIST LIMITED
NeoGen 5mm 3x Nozzle (Grey)
In Commercial Distribution

  • 15060440520256 ()
  • 05060440520259 ()
830-059

  • Nitrogen plasma skin surface treatment system

NeoGen - 05060440520242

NeoGen 25mm 3x Nozzle (Black)
ENERGIST LIMITED
NeoGen 25mm 3x Nozzle (Black)
In Commercial Distribution

  • 15060440520249 ()
  • 05060440520242 ()
830-058

  • Nitrogen plasma skin surface treatment system

NeoGen - 05060440520235

NeoGen 5mm 3x Nozzle (Black)
ENERGIST LIMITED
NeoGen 5mm 3x Nozzle (Black)
In Commercial Distribution

  • 15060440520232 ()
  • 05060440520235 ()
830-057

  • Nitrogen plasma skin surface treatment system

NeoGen - 05060440520228

NeoGen 25mm 1x Nozzle (Grey)
ENERGIST LIMITED
NeoGen 25mm 1x Nozzle (Grey)
In Commercial Distribution

  • 15060440520225 ()
  • 05060440520228 ()
830-023

  • Nitrogen plasma skin surface treatment system

NeoGen - 05060440520211

NeoGen 5mm 1x Nozzle (Grey)
ENERGIST LIMITED
NeoGen 5mm 1x Nozzle (Grey)
In Commercial Distribution

  • 15060440520218 ()
  • 05060440520211 ()
830-033

  • Nitrogen plasma skin surface treatment system

NeoGen - 05060440520204

NeoGen 25mm 1x Nozzle (Black)
ENERGIST LIMITED
NeoGen 25mm 1x Nozzle (Black)
In Commercial Distribution

  • 15060440520201 ()
  • 05060440520204 ()
830-024

  • Nitrogen plasma skin surface treatment system

NeoGen - 05060440520198

NeoGen 5mm 1x Nozzle (Black)
ENERGIST LIMITED
NeoGen 5mm 1x Nozzle (Black)
In Commercial Distribution

  • 15060440520195 ()
  • 05060440520198 ()
830-006

  • Nitrogen plasma skin surface treatment system
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