Life Warmer Quantum Battery 35-0001

GUDID 00868058000423

The Quantum Battery from LifeWarmer is an extremely powerful and intelligent battery in a small, lightweight package- weighing only 16 oz. The Quantum Battery powers the whole warming system with state-of-the-art Lithium Polymer cells harnessing 44 Volts of electrical potential. The battery, fully charged, is able to warm and maintain up to 2 units ( 900mL +/- 100mL) of cold (4C) blood products or IV solutions to a pre-set temperature of 100.4°F (38+/- 2C) at a flow rate of 100 mL/min (depending on the ambient temperature). Or, approximately 1700 mL of 20C IV solution to a set point of 38C +/- 2C at a flow rate of 200 mL/min. The Quantum Battery is built for use in the most austere and tactical environments. It is IP67 rated for water resistance and is the only portable fluid warming battery that has a disable feature on the audible alarm for tactical considerations. The Quantum Life Warmer Battery is rechargeable with a service life of 500 charge/discharge cycles. It is important to keep the Quantum Battery charged and ready for use. Always re-charge after deployment, even if the battery was not fully discharged. The battery can be kept plugged into the Quantum Charger, as the intelligent Battery senses charge demand and will charge as needed but never overcharge. The Battery has a “Status” button to check the state of charge at any moment, with 3 colored LEDs to inform the user about the condition of the battery.

LIFE WARMER INC

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Primary Device ID00868058000423
NIH Device Record Keyf48d1ee6-de20-4071-8586-0d70280471e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameLife Warmer Quantum Battery
Version Model Number63-5902
Catalog Number35-0001
Company DUNS032045686
Company NameLIFE WARMER INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
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
GS100868058000423 [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

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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 System2019-09-11 The Quantum Blood and Fluid Warming System from LifeWarmer is a Game-Changing innovation that has succeeded in closing a critica
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