- Physicians Office Resource

Percutaneous Tracheostomy Tube with Disposable Inner Cannula
Shiley - 8PERC

Device Description

A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.

Environmental Conditions

Handling Environment Temperature - Degrees Fahrenheit

120.00
N/A

Device Sizes

Length: 79 Millimeter

Inner Diameter, 7.6, mm; Outer Diameter, 12.2, mm; Cuff Resting Diameter, 27.2, mm;

Length: 79 Millimeter
Inner Diameter, 7.6, mm; Outer Diameter, 12.2, mm; Cuff Resting Diameter, 27.2, mm;

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: BTO

Device Name: Tube, Tracheostomy (W/Wo Connector)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 868.5800

Third Party Flag: Y

Medical Specialty: AN

Device Identifiers

Device Id: 50884522006703

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 30884522006709

Package Quantity: 108

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 30884522006709

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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