STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109

• K Number: K000964
• Device Name: STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
• Manufacturer: AUTOMATIC LIQUID PACKAGING, INC.
• Date Cleared: 2000-04-25 ( 29 days)
• Product Code: JOH
• Regulation Number: 868.5800

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 868.5800 Tracheostomy tube and tube cuff.

(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.

Summary

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