Life Warmer Quantum Thermal Transfusion Set for Blood and Blood Products (TTS-B)

The LifeWarmer Quantum Thermal Transfusion Set- Blood is the revolutionary IV tubing set that allows for safe, rapid warming of blood, blood products, or IV fluids without adding hardly any…

Registry build 21.09.26

The LifeWarmer Quantum Thermal Transfusion Set- Blood is the revolutionary IV tubing set that allows for safe, rapid warming of blood, blood products, or IV fluids without adding hardly any additional steps to the normal IV setup process. Modeled after standard blood 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 blood 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 (thermal resistors) 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 2 units ( 900mL +/- 100mL) of cold (4C) blood products or IV solutions to a pre-set temperature of 100.4F (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. Effective warming flow rates range from 2 to 200 mL/minute depending on input fluid temperature and ambient conditions.

1manufacturer
1catalogue number

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LGZ
Manufacturer City Province Registered as Device types
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24

Record

Regulatory record for Life Warmer Quantum Thermal Transfusion Set for Blood and Blood Products (TTS-B)
Listed by North American Rescue, LLC., United States
FDA product code LGZ
Device type Warmer, Thermal, Infusion Fluid
Device class Class 2
Regulation 21 CFR 880.5725
Establishment Specification developer, Repacker / relabeller, Manufacturer
Record published 2019-09-03
Record revised 2024-04-26 (version 4)

Specifications

Specifications
MRI safety MR Unsafe
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Box of 2

Catalogue Numbers

Catalogue numbers for Life Warmer Quantum Thermal Transfusion Set for Blood and Blood Products (TTS-B)
Catalogue number Size Status
63-5904 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Pedigo Products, Inc. Pedigo Products, Inc. 207
Amsco Steris Corporation 38
Level 1 ICU Medical, Inc 26
Skytron warming cabinet Skytron, LLC 24
ThermaCor 1200 Infusion System Smisson-Cartledge Biomedical LLC 11
Astoflo® Plus ECO Stihler Electronic Gmbh 10
enFlow Carefusion 8
Fluido® AirGuard System The Surgical Company International B.V. 7
Smithworks Medical, Inc. Smithworks, Inc. 5
Warming Cabinet Single Compartment Counter-Top Model (Glass Door) Imperial Surgical Ltd. 4
Hang&Go PAC Rand SPA 4
enFlow™ Airlife, Inc. 4

Showing 12 of 159. All products under Warmer, Thermal, Infusion Fluid

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer