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510(k) Data Aggregation
K Number
K961335Device Name
GEM PREMIER PLUS MODEL 5500
Manufacturer
MALLINCKRODT SENSOR SYSTEMS, INC.
Date Cleared
1996-06-28
(81 days)
Product Code
CHL, CEM, GKF, JFP, JGS
Regulation Number
862.1120Why did this record match?
Applicant Name (Manufacturer) :
MALLINCKRODT SENSOR SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GEM Premier Plus is designed for use by health care professionals to rapidly analyze patient whole blood samples at the point of care, in a clinical setting.
Device Description
The GEM Premier Plus is a small (12" x 10" x 16.5") Blood Gas and Electrolyte Analyzer designed for use by non-laboratory medical personnel at the point of care. The device, along with its disposable reagent cartridge is capable of measuring p02, pC02, pH, Na+, K+, iCa++ and hematocrit from a single 200uL blood sample in 104 seconds. The device will also calculate the following derived parameters - HCO3, TCO2, Base Excess, O2 Sat. The system is self calibrating with all calibration solutions, sensors, pump tubing and waste bag contained within a disposable cartridge.
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