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510(k) Data Aggregation
K Number
K023653Device Name
MAXONE IV FLUID/BLOOD WARMER, MODEL 102
Manufacturer
AUTOMATIC MEDICAL TECHNOLOGIES, INC.
Date Cleared
2003-01-17
(79 days)
Product Code
LGZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
AUTOMATIC MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MaxOne™ IV Fluid/Blood Warmer, Model 102, is indicated for the warming of blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments.
Device Description
The MaxOne™ IV Fluid/Blood Warmer consists of a single reusable heating unit with controller containing an on/off switch to be used with disposable MaxOne™ Warmer Cartridges. The device is placed in-line between a standard IV drip set and a standard IV extenstion set and is designed to warm blood, blood products and intravenous liquids at flow rates of up to and including 150 mL/min. The MaxOne™ IV Fluid/Blood Warmer will deliver temperatures at 37°C to 41.5°C. The MaxOne™ IV Fluid/Blood Warmer opens up to reveal the aluminum heating plates. A disposable sterile MaxOne™ Warmer Cartridge is placed on the supporting pins of the aluminum heating plates. Blood, blood products and intravenous solutions travel through channels in the warmer cartridge, which is surrounded by heating channels and heated by means of electrical resistance.
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K Number
K002409Device Name
MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER
Manufacturer
AUTOMATIC MEDICAL TECHNOLOGIES, INC.
Date Cleared
2001-06-28
(325 days)
Product Code
LGZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
AUTOMATIC MEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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