Portex

Basic Information

• Brand Name: Portex
• Primary DI: 15019517075809
• Version / Model: 24-1013-64
• Company Name: Smiths Medical ASD, Inc.
• Labeler DUNS: 082005361
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-09
• Public Version: 1
• Public Version Date: 2020-03-17
• Public Version Status: New
• Public Device Record Key: 6c124f5b-2de5-47e7-ab20-07c2b206adfa

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
BSP	NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)	Anesthesiology	868.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58293	Epidural needle, non-threaded	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	55019517075807	GS1	Pallet	10	In Commercial Distribution
Package	35019517075803	GS1	Case	20	In Commercial Distribution
Primary	15019517075809	GS1

Premarket Submissions

Submission Number	Supplement Number
K172823	000