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510(k) Data Aggregation
K Number
K120860Device Name
INFU BOX TYPE 0412A
Manufacturer
Date Cleared
2012-05-08
(47 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL RESCUE EQUIPMENT HOLDING AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The INFU Box is indicated for the regulation of temperature of intravenous (IV) fluid bags prior to administration. The device is intended for bags with crystalloid fluids only. Intended users are health care professionals. The device is intended for use in clinical and field environments and is intended to be mounted in a ground based field operating vehicle, such as ambulance or military vehicle.
Device Description
The INFU box warmer device is electronically regulated to obtain and maintain a preset temperature. Electronically controlled Peltier elements are used to produce a temperature difference between an internal and external airflow. The device uses environmental air to regulate the temperature. It is designed to maintain three 1000 ml IV liquid bags. The main system is powered by a 12 V DC source.
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