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510(k) Data Aggregation
K Number
K213767Device Name
Endure ETCO2/02 Nasal Cannula
Manufacturer
Endure Industries Inc
Date Cleared
2023-09-12
(650 days)
Product Code
CCK, CAT
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
Endure Industries Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endure ETCO2/O2 Nasal Cannula has two functions
- 1) It is intended to deliver supplemental Oxygen to patients and
2) to obtain CO2 sampling of exhaled air
Environment of use: The device is intended to be used in hospitals, surgery centers and other acute care centers.
Patient population: Patients requiring supplemental Oxygen and/or requiring CO2 monitoring. Intended for patients above 12 years of age.
Device Description
Endure Industries has designed an ETCO2/O2 nasal cannula and an exhaled gas sampling device. The features include sampling of CO2 from exhaled air to a capnograph. It can provide supplemental O2 and sample exhaled air at the same time. The device is configured in such a way that it has a nasal cannula with a division to deliver oxygen through one nares and sample exhaled gases through the other.
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