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Life Warmer Quantum Thermal Infusion Set (TIS)

FDA UDI

Class II (US FDA UDI)

by North American Rescue, Llc.

Identity

Trade Name
Life Warmer Quantum Thermal Infusion Set (TIS) FDA UDI
Generic Name
Conduction blood/fluid warmer FDA UDI
Device Name
The LifeWarmer Quantum Thermal Infusion Set (TIS) is the revolutionary IV tubing set that allows for safe, rapid warming of IV fluids without adding hardly any additional steps to the normal IV setup process. Modeled after standard IV infusion tubing, the familiar configuration allows for ease of use. The sophisticated intelligence and proprietary warming technology are integrated into the tubing system for simplicity and to reduce additional equipment and procedural steps. Roughly the same size and weight as standard IV tubing, there is almost no additional equipment burden. The Quantum IV administration tubing is double-extruded to yield a configuration that has both an inner tubing layer and an outer tubing layer. A conductive heating element is between the two layers but does not come in contact with the fluid path or disrupt the laminar flow. The outer tubing layer acts as an insulator while the inner tubing layer transfers the heat from the heating element to the fluid path. Thermistors located in the tubing continually measure temperature and provide that input to the Quantum Controller. The monitoring and independent application of energy (heat) along the fluid path allows the Quantum to respond to varying temperature inputs from the fluid source to near the point of patient entry to ensure fluid temperature is the right temperature at delivery. The Quantum Life Warmer, fully charged, is able to warm and maintain up to approximately 1700 mL of 20C IV solution to a set point of 100.4F (38 +/- 2C) at a flow rate of 200 mL/min. Effective warming flow rates range from 2 to 200 mL/minute depending on input fluid temperature and ambient conditions. FDA UDI
Model / Reference
63-5903 FDA UDI
Description
The LifeWarmer Quantum Thermal Infusion Set (TIS) is the revolutionary IV tubing set that allows for safe, rapid warming of IV fluids without adding hardly any additional steps to the normal IV setup process. Modeled after standard IV infusion tubing, the familiar configuration allows for ease of use. The sophisticated intelligence and proprietary warming technology are integrated into the tubing system for simplicity and to reduce additional equipment and procedural steps. Roughly the same size and weight as standard IV tubing, there is almost no additional equipment burden. The Quantum IV administration tubing is double-extruded to yield a configuration that has both an inner tubing layer and an outer tubing layer. A conductive heating element is between the two layers but does not come in contact with the fluid path or disrupt the laminar flow. The outer tubing layer acts as an insulator while the inner tubing layer transfers the heat from the heating element to the fluid path. Thermistors located in the tubing continually measure temperature and provide that input to the Quantum Controller. The monitoring and independent application of energy (heat) along the fluid path allows the Quantum to respond to varying temperature inputs from the fluid source to near the point of patient entry to ensure fluid temperature is the right temperature at delivery. The Quantum Life Warmer, fully charged, is able to warm and maintain up to approximately 1700 mL of 20C IV solution to a set point of 100.4F (38 +/- 2C) at a flow rate of 200 mL/min. Effective warming flow rates range from 2 to 200 mL/minute depending on input fluid temperature and ambient conditions. FDA UDI

Identifiers

Catalog Number
35-0004 FDA UDI
Primary DI / UDI-DI
00868058000409 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Conduction blood/fluid warmer

Life Warmer Quantum Thermal Infusion Set (TIS) by North American Rescue, Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 bb1aca92-5712-4f9f-a7a1-bffc399d5a34 34 fields · synced Jun 7, 2026