| Primary Device ID | 00868058000461 |
| NIH Device Record Key | bb1aca92-5712-4f9f-a7a1-bffc399d5a34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Life Warmer Quantum Thermal Infusion Set (TIS) |
| Version Model Number | 63-5903 |
| Catalog Number | 35-0004 |
| Company DUNS | 032045686 |
| Company Name | LIFE WARMER INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00868058000409 [Primary] |
| GS1 | 00868058000461 [Package] Contains: 00868058000409 Package: Box [2 Units] In Commercial Distribution |
| LGZ | Warmer, Thermal, Infusion Fluid |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00868058000461]
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| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-11 |
| Device Publish Date | 2019-09-03 |
| 00868058000492 - Life Warmer Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration) | 2019-11-08 The Quantum Blood and Fluid Warming System (IV Fluid ONLY Configuration) from LifeWarmer is a Game-Changing innovation that has |
| 00868058000461 - Life Warmer Quantum Thermal Infusion Set (TIS) | 2019-09-11The 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. |
| 00868058000461 - Life Warmer Quantum Thermal Infusion Set (TIS) | 2019-09-11 The Quantum Thermal Infusion Set (TIS) from LifeWarmer is the revolutionary IV tubing set that allows for safe, rapid warming of |
| 00868058000454 - Life Warmer Quantum Thermal Transfusion Set for Blood and Blood Products (TTS-B) | 2019-09-11 The Quantum Thermal Transfusion Set- Blood from LifeWarmer is the revolutionary IV tubing set that allows for safe, rapid warmin |
| 00868058000423 - Life Warmer Quantum Battery | 2019-09-11 The Quantum Battery from LifeWarmer is an extremely powerful and intelligent battery in a small, lightweight package- weighing o |
| 00868058000430 - Life Warmer Quantum Charger | 2019-09-11 The Quantum Charger from LifeWarmer is an AC-powered reusable device that can fully charge the Quantum Battery rapidly and safel |
| 00868058000447 - Life Warmer Quantum Controller | 2019-09-11 The Life Warmer Quantum Controller is the command center of the Quantum Blood and Fluid Warming System. It contains the micropro |
| 00868058000485 - Life Warmer Quantum Blood and Fluid Warming System | 2019-09-11 The Quantum Blood and Fluid Warming System from LifeWarmer is a Game-Changing innovation that has succeeded in closing a critica |