Lyka® PORT Needle Free Access Device

Basic Information

• Brand Name: Lyka® PORT Needle Free Access Device
• Primary DI: 00634624417021
• Version / Model: 4170Y
• Company Name: QUEST MEDICAL INC
• Labeler DUNS: 041810693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-12
• Public Version: 2
• Public Version Date: 2025-11-24
• Public Version Status: Update
• Public Device Record Key: d744711c-518f-46bc-adbb-3763e2645e5e

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
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63440	Haemodialysis tubing valve-connector	A small, sterile, stand-alone, Luer-activated plastic valve intended to be connected to a haemodialysis catheter to allow external tubing to be connected to the catheter in a secure, sealed, locked position until disconnection of the tubing, whereupon it is designed to seal the catheter (i.e., between haemodialysis therapies). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00634624417021	GS1
Package	10634624417028	GS1	Carton	50	In Commercial Distribution
Package	20634624417025	GS1	Shipper	4	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]