Duns Number:032045686
Device Description: The Life Warmer Quantum Controller is the command center of the Quantum Blood and Fluid Wa The Life Warmer Quantum Controller is the command center of the Quantum Blood and Fluid Warming System. It contains the microprocessor and control algorithm that continually assesses temperature input from tubing thermistors and regulates the energy provided to the tubing heating elements in the proximal and/or distal segments to reach and maintain temperature between 100.4°F (38°+/- 2°C) at patient delivery. The Controller receives power when connected to the Battery and modulates the energy flow to the TIS/TTS-B. The Quantum Controller has two connections, one for the battery and one for the Thermal Tubing of choice. The connection to the battery is an omni-directional plug for ease of insertion and the connection is safe and secure. The connection to the TIS or TTS-B is bi-directional and simple to execute- it’s plug and play.The Controller has LED lights on the shoulder of the device to inform the user about the output temperature and flow of the fluid. It will visually alert the care provider to the status of the system.The Controller is reusable and comes fitted with a Jacket that permits the mating (connection) of the TIS or TTS-B Life Warmer tubing circuit connector to the connector slot on the Controller.
Catalog Number
35-0003
Brand Name
Life Warmer Quantum Controller
Version/Model Number
63-5901
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
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
Product Code
BSB
Product Code Name
Warmer, Blood, Non-Electromagnetic Radiation
Public Device Record Key
0125da9f-e574-454a-b0b1-636401d39d1c
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
September 03, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |