Portex

Basic Information

• Brand Name: Portex
• Primary DI: 15019315107146
• Version / Model: 100/597/080CZ
• Company Name: Smiths Medical Czech Republic a.s.
• Labeler DUNS: 361330253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-04
• Public Version: 3
• Public Version Date: 2018-10-16
• Public Version Status: Update
• Public Device Record Key: 46859b9f-68e6-4d9c-8b0e-f64769f9835e

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTO	Tube, tracheostomy (w/wo connector)	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14099	Tracheostomy kit, single-use	A collection of sterile surgical instruments, dressings/swabs, syringe, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper airway obstruction and to facilitate ventilation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	55019315107144	GS1	Case	4	In Commercial Distribution
Package	35019315107140	GS1	Box	1	In Commercial Distribution
Primary	15019315107146	GS1