Search Results
Found 1 results
510(k) Data Aggregation
K Number
K173533Device Name
Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
Manufacturer
Date Cleared
2018-03-29
(134 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Poiesis Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Poiesis Medical Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.
Device Description
The Poiesis Medical Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. The device is a Foley Catheter that is used for simultaneous monitoring of the body core temperature during surgical intervals. It is composed of 100% silicone.
The Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter comes in two sizes (16Fr and 18Fr). The catheters consist of a shaft with eyelets near the tip, two (2) balloons, drainage funnel and two (2) inflation arms with cap and valve. The eyelets allow for drainage of urine from the tip of the catheter through the drainage lumen. When inflated the balloons retains the catheter within the bladder. There are four (4) lumens in each catheter: one (1) for urine drainage, two (2) for individual balloon inflation/deflation and one (1) for the temperature sensing capability. The device is EtO sterilized and is a single-use device.
Ask a Question
Ask a specific question about this device
Page 1 of 1