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510(k) Data Aggregation
K Number
K120079Device Name
PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
Manufacturer
PRIMED HALBERSTADT MEDIZINTECHNIK GMBH
Date Cleared
2012-05-24
(135 days)
Product Code
BTO
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
PRIMED HALBERSTADT MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Primed Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.
Device Description
The Primed Tracheostomy Tubes consists of various types of tracheostomy tubes, e.g., Primedistom Cannulas w/wo cuff, Silver Cannulas, Priflex Cannulas, Silicone Cannulas (Primedi Silk), and Primedi Star Cannulas. The tracheostomy tubes are made of different materials and offer a variety of inner and outer diameters and varying lengths thus making it possible to meet the individual needs of a patient.
The Primed Tracheostomy Tubes can be obtained sieved or unsieved, with or without speaking valve, cuffed or uncuffed, with or without one or two inner cannulas. The accessories comprise different speaking valves as well as Humid Moist Exchangers (HME) and different types of filters.
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