Life Warmer Quantum Controller

Primary DI
00868058000447
Brand
Life Warmer Quantum Controller
Company
NORTH AMERICAN RESCUE, LLC
Model
63-5901
Catalog number
35-0003
Device description
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.
Published
2019-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BSBWarmer, Blood, Non-Electromagnetic Radiation
LGZWarmer, Thermal, Infusion Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSBWarmer, Blood, Non-Electromagnetic RadiationHematology2
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181775000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181775000Quantum Blood and IV Fluid Infusion WarmerLife Warmer, Inc.2019-01-28LGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868058000447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868058000447008680580004478680580004470868058000447

GMDN Terms#

Term, Definition table
TermDefinition
Conduction blood/fluid warmerA mains electricity (AC-powered) device, which may include rechargeable batteries, designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832426782
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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