Life Warmer Quantum Blood and Fluid Warming System 35-0006

GUDID 00868058000485

The Quantum Blood and Fluid Warming System from LifeWarmer 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

LIFE WARMER INC

Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer Conduction blood/fluid warmer
Primary Device ID00868058000485
NIH Device Record Key8bf8852e-10ec-4449-ac24-fb0e63ecba33
Commercial Distribution StatusIn Commercial Distribution
Brand NameLife Warmer Quantum Blood and Fluid Warming System
Version Model Number63-5900
Catalog Number35-0006
Company DUNS032045686
Company NameLIFE WARMER INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100868058000485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGZWarmer, Thermal, Infusion Fluid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-11
Device Publish Date2019-09-03

Devices Manufactured by LIFE WARMER INC

00868058000492 - Life Warmer Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration)2019-11-08 The Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration) from LifeWarmer is a Game-Changing innovation that has
00868058000461 - Life Warmer Quantum Thermal Infusion Set (TIS)2019-09-11 The Quantum Thermal Infusion Set (TIS) from LifeWarmer is the revolutionary IV tubing set that allows for safe, rapid warming of
00868058000454 - Life Warmer Quantum Thermal Transfusion Set for Blood and Blood Products (TTS-B)2019-09-11 The Quantum Thermal Transfusion Set- Blood from LifeWarmer is the revolutionary IV tubing set that allows for safe, rapid warmin
00868058000423 - Life Warmer Quantum Battery2019-09-11 The Quantum Battery from LifeWarmer is an extremely powerful and intelligent battery in a small, lightweight package- weighing o
00868058000430 - Life Warmer Quantum Charger2019-09-11 The Quantum Charger from LifeWarmer is an AC-powered reusable device that can fully charge the Quantum Battery rapidly and safel
00868058000447 - Life Warmer Quantum Controller2019-09-11 The Life Warmer Quantum Controller is the command center of the Quantum Blood and Fluid Warming System. It contains the micropro
00868058000485 - Life Warmer Quantum Blood and Fluid Warming System2019-09-11The Quantum Blood and Fluid Warming System from LifeWarmer 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
00868058000485 - Life Warmer Quantum Blood and Fluid Warming System2019-09-11 The Quantum Blood and Fluid Warming System from LifeWarmer is a Game-Changing innovation that has succeeded in closing a critica

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.