Flush Device 041300003A

GUDID 20886333201567

Flush Device 3mL/hr

ARGON MEDICAL DEVICES, INC.

Invasive blood pressure transducer set Invasive blood pressure transducer set

• Primary Device ID: 20886333201567
• NIH Device Record Key: 8ba2a03f-a033-48c7-b2f7-ded0ec9774f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flush Device
• Version Model Number: 041300003A
• Catalog Number: 041300003A
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333201563 [Primary]
GS1	20886333201567 [Package]; Contains: 00886333201563; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070384

FDA Product Code

• KRA: Catheter, Continuous Flush

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-09-12

On-Brand Devices [Flush Device]

• 20886333201574: Flush Device 3mL/HR F in M/F out
• 20886333201567: Flush Device 3mL/hr