Life Warmer Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration) - The Quantum Blood and Fluid Warming System (IV - LIFE WARMER INC

Duns Number:032045686

Device Description: The Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration) from LifeWarmer i The Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration) 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 Controller1 x Battery1 x Battery Charger2 x TIS (Thermal Infusion Set)NOTE: TIS is Single Use Only, Supplied sterile via Ethylene Oxide and Not Intended for use with Blood and Blood Products

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More Product Details

Catalog Number

35-0007

Brand Name

Life Warmer Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration)

Version/Model Number

63-5906

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

BSB

Product Code Name

Warmer, Blood, Non-Electromagnetic Radiation

Device Record Status

Public Device Record Key

af3ceca2-09de-4bcb-bd8f-f60d0a3db52c

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

October 31, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFE WARMER INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7