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510(k) Data Aggregation
K Number
K223625Device Name
CapnoSpot Pneumothorax Decompression Indicator
Manufacturer
Pneumeric, Inc.
Date Cleared
2023-03-28
(113 days)
Product Code
GAA
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
Pneumeric, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used for more accurate placement of pneumothorax decompression devices than the current standard of care auditory assessments. The Pneumothorax Decompression Indicator is a colorimetric capnography device indicated to detect the carbon dioxide in the gas passing through the device used to treat pneumothorax with suspected tension physiology.
Device Description
The Pneumeric Capnospot Pneumothorax Decompression Indicator is a capnography device that provides objective, real-time feedback during decompressive thoracostomy. Specifically, the device detects the presence of carbon dioxide in the gas from the decompressed pneumothorax, permitting more accurate placement of the needle or thoracostomy device compared to the current standard of care based upon auditory assessments.
The Pneumeric Capnospot is a therapeutic device intended to guide the placement of pneumothorax decompression needles and thoracostomy devices.
The product consists of a cylindrical polycarbonate tube containing a carbon dioxide detecting paper. The device has a male luer connector on the distal end of the device to connect to decompression needles and thoracostomy devices, a diaphragm to prevent backflow of gases, a color changing indicator and a female luer on the proximal end of the device that can be used to connect accessories.
The product is shipped non-sterile and labeled for single use only.
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