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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Incubator; 10 Liter (.35 cubic feet)
LW SCIENTIFIC, INC.
ICL-010L-D032
In Commercial Distribution

  • 00664816002308 ()
ICL-010L-D032

  • Multi-purpose warming cabinet, stationary
Water Bath - circulating, variable temp, 10 liter, 110V
LW SCIENTIFIC, INC.
WBL-10LC-SSD1
In Commercial Distribution

  • 00664816001592 ()
WBL-10LC-SSD1

  • Laboratory water bath
Water Bath - circulating, variable temp, 20 liter, 110V
LW SCIENTIFIC, INC.
WBL-20LC-SSD1
In Commercial Distribution

  • 00664816001431 ()
WBL-20LC-SSD1

  • Laboratory water bath
Pipette Shaker - timer, 2500 rpms, holds 6
LW SCIENTIFIC, INC.
SHL-PPF7-06F1
In Commercial Distribution

  • 00664816001400 ()
SHL-PPF7-06F1

  • Laboratory shaker
Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines, Series 800 Infant Mask
WESTMED, INC.
7-N7915-56I-62
In Commercial Distribution

  • 20709078081846 ()
  • 00709078081842 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Manometer, 40cm Pop-off Valve
WESTMED, INC.
7-N7905-MAN-P
In Commercial Distribution

  • 20709078063897 ()
  • 00709078063893 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines, Series 900 Neonatal Mask
WESTMED, INC.
7-N7905-N
In Commercial Distribution

  • 20709078063866 ()
  • 00709078063862 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines, Series 900 Infant Mask
WESTMED, INC.
7-N7905-I
In Commercial Distribution

  • 00709078063855 ()
  • 20709078063859 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Manometer, Series 900 Neonatal Mask
WESTMED, INC.
7-N7905-N-MAN
In Commercial Distribution

  • 20709078063835 ()
  • 00709078063831 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Manometer
WESTMED, INC.
7-N7905-MAN
In Commercial Distribution

  • 20709078063828 ()
  • 00709078063824 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Manometer, Seires 900 Infant Mask
WESTMED, INC.
7-N7905-I-MAN
In Commercial Distribution

  • 00709078063817 ()
  • 20709078063811 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1L Breathing Bag (Latex Free), 7' O2 and Manometer
WESTMED, INC.
7-N7901-MAN
In Commercial Distribution

  • 00709078063800 ()
  • 20709078063804 ()


  • Ventilator breathing circuit, single-use
Hyperinflation Elbow, 7' O2 and Pressure Lines
WESTMED, INC.
7-N7910
In Commercial Distribution

  • 20709078060308 ()
  • 00709078060304 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 2L Breathing Bag (Latex Free), 7' KROT
WESTMED, INC.
MC79020220
In Commercial Distribution

  • 20709078060193 ()
  • 00709078060199 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines, Series 800 Infant Mask
WESTMED, INC.
7-N7915-62-29I
In Commercial Distribution

  • 20709078060100 ()
  • 00709078060106 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 3L Breathing Bag (Latex Free), 7' O2 and Pressure Lines
WESTMED, INC.
7-N7903-62
In Commercial Distribution

  • 20709078060087 ()
  • 00709078060083 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines
WESTMED, INC.
7-N7902-62
In Commercial Distribution

  • 00709078060069 ()
  • 20709078060063 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1L Breathing Bag, (Latex Free) 7' O2 and Pressure Lines
WESTMED, INC.
7-N7901-62
In Commercial Distribution

  • 00709078060045 ()
  • 20709078060049 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines
WESTMED, INC.
7-N7905-62
In Commercial Distribution

  • 20709078060025 ()
  • 00709078060021 ()


  • Ventilator breathing circuit, single-use
Disposable Hyperinflation System, 1/2L Breathing Bag (Latex Free), 7' O2 and Pressure Lines
WESTMED, INC.
7-N7905
In Commercial Distribution

  • 20709078060018 ()
  • 00709078060014 ()


  • Ventilator breathing circuit, single-use
Universal Neonatal Transport Circuit with Lavabed
WESTMED, INC.
9402U
Not in Commercial Distribution

  • 00709078006005 ()
  • 10709078006002 ()


  • Heated respiratory humidifier
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
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
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- 6ft Light Gray Smoothbore CPAP Tubing - Slim Style
SUNSET HEALTHCARE SOLUTIONS, INC.
TUB006SSRP
In Commercial Distribution

  • 00848530070670 ()


  • Heated respiratory humidifier
(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
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
Neonatal Transport Humidification System
INTERNATIONAL BIOMEDICAL, LTD.
9400
In Commercial Distribution

  • 00850018561648 ()
9400

  • Heated respiratory humidifier
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
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
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™ Breathing Circuit Pediatric Respiratory Circuit Heated
AIRLIFE
10794-H12
In Commercial Distribution

  • 30889483572904 ()
  • 10889483572900 ()
10794-H12

  • Ventilator breathing circuit, single-use
Isothermal™ Adult Respiratory Breathing Circuit Non-heated
AIRLIFE
10746-855
In Commercial Distribution

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

  • Ventilator breathing circuit, single-use
Isothermal Pediatric Respiratory Breathing Circuit Non-heated
AIRLIFE
10608-701
In Commercial Distribution

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

  • Ventilator breathing circuit, single-use
Isothermal™ Breathing Circuit Adult Respiratory Circuit Non–heated
AIRLIFE
10604-855
In Commercial Distribution

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

  • Ventilator breathing circuit, single-use
Isothermal™ Breathing Circuit Accessory
AIRLIFE
10471-504
In Commercial Distribution

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

  • Ventilator breathing circuit, single-use
Isothermal Breathing Circuit Pediatric Inspiratory Line Heated
AIRLIFE
10333-504
In Commercial Distribution

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

  • Ventilator breathing circuit, single-use
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
Isothermal™ Breathing Circuit Adult Respiratory Circuit Non–heated
AIRLIFE
10281-855
In Commercial Distribution

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

  • Ventilator breathing circuit, single-use
Isothermal Breathing Circuit Accessory - 10mm Inspiratory line Extension
AIRLIFE
10225-504
In Commercial Distribution

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

  • Ventilator breathing circuit, single-use
Isothermal Breathing Circuit Accessory
AIRLIFE
10155N-504
In Commercial Distribution

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

  • Ventilator breathing circuit, single-use
Isothermal Breathing Circuit Adult Inspiratory Line Heated
AIRLIFE
1006-H05
In Commercial Distribution

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

  • Ventilator breathing circuit, single-use
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™ 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™ 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™ 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™ 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
Isothermal™ Breathing Circuit Infant Respiratory Circuit
AIRLIFE
0260-503
In Commercial Distribution

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

  • Ventilator breathing circuit, single-use
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™ Smooth Bore Breathing Circuit
AIRLIFE
003769
In Commercial Distribution

  • 30889483571709 ()
  • 10889483571705 ()
003769

  • Ventilator breathing circuit, single-use
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