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510(k) Data Aggregation
K Number
K050381Device Name
CS MEDICAL TTCF GAS DELIVERY SYSTEM
Manufacturer
CS MEDICAL INC.
Date Cleared
2005-07-13
(148 days)
Product Code
BZR
Regulation Number
868.5330Why did this record match?
Applicant Name (Manufacturer) :
CS MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TTCF is indicated for the treatment of hypoxemia with delivery of transtracheal high flows of a heated and humidified air/oxygen mixture to self-breathing patients with a cuff deflated fenestrated tracheostomy tube. TTCF is indicated for hospital use in adult patients.
Device Description
The TTCF Gas Delivery System is a gas supply and humidification system mounted on a medical stand. Components include an oxygen blender, a flow meter, pressure relief valve, humidifier, and pressure monitor. A blended source of compressed air and oxygen allow choosing flow rate and FiO2 of the mixture. Flows are delivered at 6-15 LPM. Oxygen concentrations are available from 21% to 77%.
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K Number
K050379Device Name
CS MEDICAL ADULT TTCF CATHETER
Manufacturer
CS MEDICAL INC.
Date Cleared
2005-07-12
(147 days)
Product Code
BTO
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
CS MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TTCF is indicated for the treatment of hypoxemia with delivery of transtracheal high flows of a heated and humidified air/oxygen mixture to self-breathing patients with a cuff deflated fenestrated tracheostomy tube. TTCF is indicated for hospital use in adult patients.
Device Description
The TTCF Catheter is constructed of clear, latex-free plastics with a radiopaque stripe for identification by x-ray. A rounded tip facilitates insertion and minimizes potential mucous irritation or injury. The catheter is 4 mm O.D. used within an adult Portex Blue Line Fenestrated Tracheostomy Tube. Inner diameter is 3.1 mm in 11.5, 13.5 and 15.5 cm lengths. The distal end is an 11 mm connector capable of attaching to the CS Medical Mid-section Hose. The catheter is supplied sterile and designed as single patient use.
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