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

Conduction blood/fluid warmer

• Primary Device ID: 00868058000423
• NIH Device Record Key: f48d1ee6-de20-4071-8586-0d70280471e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Life Warmer Quantum Battery
• Version Model Number: 63-5902
• Catalog Number: 35-0001
• Company DUNS: 032045686
• Company Name: LIFE WARMER INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868058000423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181775

FDA Product Code

• LGZ: Warmer, Thermal, Infusion Fluid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-11
• Device Publish Date: 2019-09-03

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 Battery: 2019-09-11The 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.
• 00868058000423 - Life Warmer Quantum Battery: 2019-09-11 The Quantum Battery from LifeWarmer is an extremely powerful and intelligent battery in a small, lightweight package- weighing o
• 00868058000430 - Life Warmer Quantum Charger: 2019-09-11 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 Controller: 2019-09-11 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 System: 2019-09-11 The Quantum Blood and Fluid Warming System from LifeWarmer is a Game-Changing innovation that has succeeded in closing a critica