Portex - 100/855/000
Device Description
A non-sterile device intended to be used to clean the inner cannula of a tracheostomy tube that has been removed from the in situ tracheostomy tube. It typically consists of a flexible shaft, which in itself can act as a handle, with a swab made of foam or bristles at the distal end. It is used by a patient or healthcare provider to remove secretions from the inside of the inner cannula. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
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 IdentifiersDevice Id: 35019315052891
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15019315052897
Package Quantity: 2
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 15019315052897
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
Device Id: 55019315052895
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 35019315052891
Package Quantity: 40
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 05019315052890
Device Type: Unit of Use
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