Monitoring Kit 042510601A

GUDID 20886333201888

Monitoring Kit - St Louis University

ARGON MEDICAL DEVICES, INC.

Intravenous line stopcock

• Primary Device ID: 20886333201888
• NIH Device Record Key: a60ec7f0-853a-4861-b1bf-5ca11599ca2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monitoring Kit
• Version Model Number: 042510601A
• Catalog Number: 042510601A
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333201884 [Primary]
GS1	20886333201888 [Package]; Contains: 00886333201884; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K780271

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: 2016-09-20

On-Brand Devices [Monitoring Kit]

• 20886333202007: Monitoring Kit
• 20886333201888: Monitoring Kit - St Louis University