Lyka® PORT Needle Free Access Device

GUDID 00634624417021

QUEST MEDICAL INC

Haemodialysis tubing valve-connector

• Primary Device ID: 00634624417021
• NIH Device Record Key: d744711c-518f-46bc-adbb-3763e2645e5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lyka® PORT Needle Free Access Device
• Version Model Number: 4170Y
• Company DUNS: 041810693
• Company Name: QUEST MEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 800-627-0226
• Email: custserv@questmedical.com
• Phone: +1 800-627-0226
• Email: custserv@questmedical.com
• Phone: +1 800-627-0226
• Email: custserv@questmedical.com
• Phone: +1 800-627-0226
• Email: custserv@questmedical.com
• Phone: +1 800-627-0226
• Email: custserv@questmedical.com
• Phone: +1 800-627-0226
• Email: custserv@questmedical.com
• Phone: +1 800-627-0226
• Email: custserv@questmedical.com
• Phone: +1 800-627-0226
• Email: custserv@questmedical.com
• Phone: +1 800-627-0226
• Email: custserv@questmedical.com
• Phone: +1 800-627-0226
• Email: custserv@questmedical.com
• Phone: +1 800-627-0226
• Email: custserv@questmedical.com
• Phone: +1 800-627-0226
• Email: custserv@questmedical.com
• Phone: +1 800-627-0226
• Email: custserv@questmedical.com
• Phone: +1 800-627-0226
• Email: custserv@questmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634624417021 [Primary]
GS1	10634624417028 [Package]; Package: Carton [50 Units]; In Commercial Distribution
GS1	20634624417025 [Package]; Contains: 10634624417028; Package: Shipper [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241058

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-20
• Device Publish Date: 2025-06-12

Devices Manufactured by QUEST MEDICAL INC

• 00634624417021 - Lyka® PORT Needle Free Access Device: 2025-06-20
• 00634624417021 - Lyka® PORT Needle Free Access Device: 2025-06-20
• 20634624530380 - MPS 3 ISO Medical Air Hose Kit: 2023-10-24
• 20634624530397 - MPS 3 Drug Pump Cover: 2023-04-03
• 20634624101153 - Q2 IV Administration Set: 2022-12-14
• 20634624101252 - Q2 IV Administration Set: 2022-12-14
• 20634624101306 - Q2 IV Administration Set: 2022-12-14
• 20634624601257 - Q2 IV Administration Set: 2022-12-14
• 20634624921096 - High-Flow 4-Way Stopcock: 2022-12-14