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510(k) Data Aggregation
K Number
K200916Device Name
Patient Administration Set
Manufacturer
Date Cleared
2020-09-01
(148 days)
Product Code
Regulation Number
892.1390Why did this record match?
Applicant Name (Manufacturer) :
Cyclomedica Australia Pty Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Patient Administration Set is a radionuclide rebreathing system and an accessory intended solely for use with the Technegas® Generator. It is designed for use as a conduit system to contain a radionuclide-labeled aerosol and permit respiration by the patient during a functional lung ventilation imaging diagnostic procedure.
Device Description
The Patient Administration Sets (PAS) consist of a flexible plastic tubing with a distal plastic connector which can be affixed to a radionuclide generator, a T-section connector with (2) one way valves which permits inhalation of the generated radionuclide gas and subsequent absorption of expelled gas during exhalation via a semipermeable microparticle filer. A mouthpiece (choice of soft silicone or hard plastic) is affixed to the proximal end of T-section connector for patient breathing.
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