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510(k) Data Aggregation
K Number
K242336Device Name
hygh-tec Drainage II
Manufacturer
AMB Medtec
Date Cleared
2025-01-17
(163 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
AMB Medtec
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The hygh-tec drainage II is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liquid stools and to provide access for the administrations. The device is not intended for use on pediatric patients.
Device Description
The hygh-tec drainage II is a fecal drainage system that is comprised of a stool collection bag, and an inflating syringe. The device is used by healthcare professional heatthcare environment for continuous trans-anal drainage and collection of stools. The stool drainage tool is the patient while a liquid is infused within a specialized port to irigate the rectum. The organic matter then progresses through the drainage tube where it is eventually stored in the collection bag for evaluation or disposal. Along with stool drainage, the hygh-tec drainage II system can be used for the administration that would be prescribed by physicians.
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