3 Port Manifold - Left/Off/Open Body - 500 PSI 193123

GUDID 20886333207040

3 Port Manifold - Left/Off/Open Body - 500 PSI

ARGON MEDICAL DEVICES, INC.

Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose Fluid transfer set, general-purpose

• Primary Device ID: 20886333207040
• NIH Device Record Key: 53f549b3-f2c4-49a6-b6ed-51105f8a4aeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3 Port Manifold - Left/Off/Open Body - 500 PSI
• Version Model Number: 193123
• Catalog Number: 193123
• Company DUNS: 140727624
• Company Name: ARGON MEDICAL DEVICES, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333207046 [Primary]
GS1	20886333207040 [Package]; Contains: 00886333207046; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K915301

FDA Product Code

• DTL: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-22

Devices Manufactured by ARGON MEDICAL DEVICES, INC.

• 00886333227167 - CLEANER Vac™: 2024-04-25 CLEANER Vac™ Thrombectomy System - 18F OD x 115cm
• 00886333227174 - Cleaner Vac™: 2024-04-25 Cleaner Vac™ - 18F OD x 115cm Aspiration Catheter with Handpiece
• 00886333227624 - Cleaner Vac™: 2024-04-25 Cleaner Vac™ Aspiration Canister
• 00886333225743 - Kodiak: 2023-07-10 Kodiak™ Dual Port Coaxial Introducer Kit
• 20886333227284 - Co-Axial Introducer Needle: 2023-06-16 Co-Axial Introducer Needle 15ga x 6.8cm
• 20886333227383 - Percutaneous Introducer: 2023-04-19 Percutaneous Introducer with Depth Marks 4F x 25cm
• 20886333227390 - Percutaneous Introducer: 2023-04-19 Percutaneous Introducer with Depth Marks 4F x 45cm
• 20886333227406 - Percutaneous Introducer: 2023-04-19 Percutaneous Introducer with Depth Marks 4F x 65cm