Portex

Basic Information

• Brand Name: Portex
• Primary DI: 20351688074901
• Version / Model: A3678
• Company Name: SMITHS MEDICAL ASD, INC.
• Labeler DUNS: 137835299
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-04
• Public Version: 5
• Public Version Date: 2019-10-08
• Public Version Status: Update
• Public Device Record Key: 992bcb2d-bb50-4862-bb1f-e2a2d6258c83
• Distribution End Date: 2019-08-13

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
CAZ	Anesthesia conduction kit	Anesthesiology	868.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61752	General-purpose catheter connector, non-sterile	A small, non-sterile device intended to create a mechanical union between a catheter and an external device (e.g., external drainage system) typically via a Luer connection; it is not dedicated to a specific type of catheter. It may be used to permit catheter insertion and/or manipulation, and/or to facilitate delivery or extraction of substances through the catheter lumen. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30351688074908	GS1	Box	10	Not in Commercial Distribution	2019-08-13
Primary	20351688074901	GS1

Premarket Submissions

Submission Number	Supplement Number
K092657	000