Duns Number:032045686
Device Description: The Quantum Battery from LifeWarmer is an extremely powerful and intelligent battery in a 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.
Catalog Number
35-0001
Brand Name
Life Warmer Quantum Battery
Version/Model Number
63-5902
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181775
Product Code
BSB
Product Code Name
Warmer, Blood, Non-Electromagnetic Radiation
Public Device Record Key
f48d1ee6-de20-4071-8586-0d70280471e3
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
September 03, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 7 |