Product Overview

Portex - 100/549/000CZ


Device Description

A non-dedicated metal wire designed to position a catheter or similar interventional device (e.g., a dilator or an endoscope) within a lumen of the gastrointestinal (GI) tract, the tracheobronchial tree, and the urinary tract (i.e., not dedicated to either clinical application). Typically, the catheter is advanced over the wire after the wire has been manoeuvred to a treatment site (e.g., site of stent-placement). It is available in a variety of diameters and lengths, may have fluoroscopic markers, or be fitted with an introducer for entering the working channel of the catheter or other interventional device. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


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: 55019315103009

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 35019315103005

Package Quantity: 20

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE


Device Id: 35019315103005

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15019315103001

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BOX


Device Id: 15019315103001

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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