Life Warmer Quantum Controller

FDA UDI

Class II (US FDA UDI)

by North American Rescue, Llc.

Identity

Trade Name: Life Warmer Quantum Controller FDA UDI
Generic Name: Conduction blood/fluid warmer FDA UDI
Device Name: The Life Warmer Quantum Controller is the command center of the Quantum Blood and Fluid Warming System. It contains the microprocessor and control algorithm that continually assesses temperature input from tubing thermistors and regulates the energy provided to the tubing heating elements in the proximal and/or distal segments to reach and maintain temperature between 100.4°F (38°+/- 2°C) at patient delivery. The Controller receives power when connected to the Battery and modulates the energy flow to the TIS/TTS-B. The Quantum Controller has two connections, one for the battery and one for the Thermal Tubing of choice. The connection to the battery is an omni-directional plug for ease of insertion and the connection is safe and secure. The connection to the TIS or TTS-B is bi-directional and simple to execute- it’s plug and play. The Controller has LED lights on the shoulder of the device to inform the user about the output temperature and flow of the fluid. It will visually alert the care provider to the status of the system. The Controller is reusable and comes fitted with a Jacket that permits the mating (connection) of the TIS or TTS-B Life Warmer tubing circuit connector to the connector slot on the Controller. FDA UDI
Model / Reference: 63-5901 FDA UDI
Description: The Life Warmer Quantum Controller is the command center of the Quantum Blood and Fluid Warming System. It contains the microprocessor and control algorithm that continually assesses temperature input from tubing thermistors and regulates the energy provided to the tubing heating elements in the proximal and/or distal segments to reach and maintain temperature between 100.4°F (38°+/- 2°C) at patient delivery. The Controller receives power when connected to the Battery and modulates the energy flow to the TIS/TTS-B. The Quantum Controller has two connections, one for the battery and one for the Thermal Tubing of choice. The connection to the battery is an omni-directional plug for ease of insertion and the connection is safe and secure. The connection to the TIS or TTS-B is bi-directional and simple to execute- it’s plug and play. The Controller has LED lights on the shoulder of the device to inform the user about the output temperature and flow of the fluid. It will visually alert the care provider to the status of the system. The Controller is reusable and comes fitted with a Jacket that permits the mating (connection) of the TIS or TTS-B Life Warmer tubing circuit connector to the connector slot on the Controller. FDA UDI

Identifiers

Catalog Number: 35-0003 FDA UDI
Primary DI / UDI-DI: 00868058000447 FDA UDI
FDA Product Code: LGZ FDA UDI
BSB FDA UDI
GMDN Term: Conduction blood/fluid warmer FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Conduction blood/fluid warmer

Life Warmer Quantum Controller by North American Rescue, Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: North American Rescue, Llc.

Sources (1)

FDA UDI 0125da9f-e574-454a-b0b1-636401d39d1c 34 fields · synced May 30, 2026