Life Warmer Quantum Thermal Transfusion Set for Blood and Blood Products (TTS-B) - The Quantum Thermal Transfusion Set- Blood from - LIFE WARMER INC

Duns Number:032045686

Device Description: The Quantum Thermal Transfusion Set- Blood from LifeWarmer is the revolutionary IV tubing The Quantum Thermal Transfusion Set- Blood from LifeWarmer 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 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.

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More Product Details

Catalog Number

35-0005

Brand Name

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

Version/Model Number

63-5904

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

Yes

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,K181775

Product Code Details

Product Code

BSB

Product Code Name

Warmer, Blood, Non-Electromagnetic Radiation

Device Record Status

Public Device Record Key

26ca82af-b2fc-4597-a211-f5990518f1ad

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

September 03, 2019

Additional Identifiers

Package DI Number

00868058000454

Quantity per Package

2

Contains DI Package

00868058000416

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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