Manifold 193107

GUDID 20886333206982

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

ARGON MEDICAL DEVICES, INC.

Fluid transfer set, general-purpose

• Primary Device ID: 20886333206982
• NIH Device Record Key: d733d325-b735-4300-8ab3-6180e46c1bd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Manifold
• Version Model Number: 193107
• Catalog Number: 193107
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00886333206988 [Primary]
GS1	20886333206982 [Package]; Contains: 00886333206988; 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: 2016-09-09

On-Brand Devices [Manifold]

• 20886333219685: 3 Port Manifold - Los Alamitos General Hospital
• 20886333207156: 4 Port Manifold Left/Off/Finger Grip - 500 PSI
• 20886333207132: 2 Port Manifold w/6" Ext. Right/Off/Finger Grip - 200 PSI
• 20886333207125: 2 Port Manifold w/6" Ext. Right/On/Finger Grip - 200 PSI
• 20886333207095: 4 Port Manifold - Right/Off/Open Body - 500 PSI
• 20886333207088: 4 Port Manifold - Right/On/Open Body - 500 PSI
• 20886333207071: 3 Port Manifold - Left/Off/Block Body - 500 PSI
• 20886333207064: 3 Port Manifold - Right/Off/Block Body - 500 PSI
• 20886333207057: 3 Port Manifold - Right/On/Finger Grip - 500 PSI
• 20886333207033: 3 Port Manifold - Right/Off/Open Body - 500 PSI
• 20886333207019: 2 Port Manifold - Left/Off/Block Body - 500 PSI
• 20886333207002: 2 Port Manifold - Right/Off/Block Body - 500 PSI
• 20886333206982: 2 Port Manifold - Left/Off/Open Body - 500 PSI
• 20886333206975: 2 Port Manifold - Right/Off/Open Body - 500 PSI
• 20886333206968: 2 Port Manifold - Right/On/Open Body - 500 PSI
• 20886333202618: Manifold 5 Unit w/ Lt. Male Adapter