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

FDA UDI

Class II (US FDA UDI)

by North American Rescue, Llc.

Identity

Trade Name
Life Warmer Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration) FDA UDI
Generic Name
Conduction blood/fluid warmer FDA UDI
Device Name
The Lifewarmer Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration) 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 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 FDA UDI
Model / Reference
63-5906 FDA UDI
Description
The Lifewarmer Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration) 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 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 FDA UDI

Identifiers

Catalog Number
35-0007 FDA UDI
Primary DI / UDI-DI
00868058000492 FDA UDI
FDA Product Code
BSB FDA UDI
LGZ FDA UDI
GMDN Term
Conduction blood/fluid warmer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9205 FDA UDI
880.5725 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Conduction blood/fluid warmer

Life Warmer Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration) by North American Rescue, Llc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Conduction blood/fluid warmer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
North American Rescue, Llc.

Sources (1)

  • FDA UDI af3ceca2-09de-4bcb-bd8f-f60d0a3db52c 34 fields · synced May 30, 2026