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510(k) Data Aggregation
K Number
K220854Device Name
TrachCuff Cuff Controller
Manufacturer
AW Technologies ApS
Date Cleared
2023-04-14
(387 days)
Product Code
BSK
Regulation Number
868.5750Why did this record match?
Applicant Name (Manufacturer) :
AW Technologies ApS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TrachCuff Cuff Controller is intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation.
The TrachCuff Cuff Controller can be used with any mechanical ventilator.
The TrachCuff Cuff Controller is to be used during ventilation of adults at least 18 years who are intubated with ETT or TT, in the following areas:
- In the intensive care ward by Respiratory Therapist
Prescription use only.
Device Description
The TrachCuff Cuff Controller is an automatic cuff pressure controller specified for use in professional healthcare environments. The device provides the operator with the means to set and control the pressure for cuffed endotracheal tubes and cuffed tracheostomy tubes during mechanical ventilation, and continuous monitoring of the set cuff pressure with alarms.
The TrachCuff Cuff Controller is mains powered via a Mains to DC power adapter, and the enclosure may be mounted on a bed rail by means of an optional mounting bracket.
The TrachCuff Cuff Controller is provided in an enclosure with touch screen operator panel.
It is designed for immediate use; no calibration or maintenance is required. A largescale display and convenient and intuitive interaction buttons maximize safe use and visibility of all important data.
The associated accessories include:
- Disposable Tubing Set with Filter .
- Device Mount Solution Bedside Mounting Bracket. .
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