Portex

Basic Information

• Brand Name: Portex
• Primary DI: 15019517054651
• Version / Model: 24-1000-64
• 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: 2
• Public Version Date: 2020-05-20
• Public Version Status: Update
• Public Device Record Key: ccd0d171-7d71-46c3-a6bb-6577e1c7845f

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
BSN	FILTER, CONDUCTION, ANESTHETIC	Anesthesiology	868.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31245	Anaesthesia conduction filter	A sterile microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during administration to a patient (e.g., through an anaesthesia conduction catheter). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	55019517054659	GS1	Pallet	7	In Commercial Distribution
Package	35019517054655	GS1	Case	10	In Commercial Distribution
Primary	15019517054651	GS1

Premarket Submissions

Submission Number	Supplement Number
K172410	000