Portex

Basic Information

• Brand Name: Portex
• Primary DI: 15019315110528
• Version / Model: 100/465/060CZ
• 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: 2017-05-29
• Public Version: 6
• Public Version Date: 2019-06-24
• Public Version Status: Update
• Public Device Record Key: ada86ee5-ff99-45a2-846d-43536b57e302

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
BWC	Needle, emergency airway	Anesthesiology	868.5090	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45926	Cricothyrotomy kit, single-use	A collection of sterile devices designed to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds allowing for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage to the upper airway tract, and prior to tracheostomy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15019315110528	GS1
Package	35019315110522	GS1	BOX	1	In Commercial Distribution
Package	55019315110526	GS1	CASE	10	In Commercial Distribution