Quantum Blood And Fluid Warming System
Life Warmer, Inc.
LIFE WARMER, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015423479 | 3015423479 | LIFE WARMER, INC. | 1 | N | 2020-04-25 | 4813 Keller Springs Road Addison TX US 75001 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 228887 | 1598484807 | K181775 | Quantum Blood and IV Fluid Infusion Warmer | LGZ | 2019-01-28 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LGZ | 1 | 2019-01-28 |
PMN#
Quantum Blood And IV Fluid Infusion Warmer
Life Warmer, Inc.
GUDID#
Life Warmer Quantum Thermal Infusion Set (TIS) - The Quantum Thermal Infusion Set (TIS) from LifeWarmer 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.
2019-09-03
Life Warmer Quantum Thermal Transfusion Set for Blood and Blood Products (TTS-B) - 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.
2019-09-03