Pediatric Tracheostomy Tube with TaperGuar Cuff
Shiley - 5.5PCF
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
- 120.00
- N/A
Device Sizes
- Angle, 120, Degrees; Inner Diameter, 5.5, MM; Length, 46, MM; Outer Diameter, 7.9, MM; SizeA, 15.8, MM; SizeB, 0, MM; SizeC, 30.2, MM
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JOH
Device Name: Tube Tracheostomy And Tube Cuff
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 IdentifiersDevice Id: 20884521103563
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521103566
Package Quantity: 48
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 10884521103566
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