Retia Medical

GUDID 00860001506471

Argos LAN Connectivity Kit

RETIA MEDICAL, LLC

Noninvasive haemodynamic monitoring system Noninvasive haemodynamic monitoring system Noninvasive haemodynamic monitoring system Noninvasive haemodynamic monitoring system Noninvasive haemodynamic monitoring system Noninvasive haemodynamic monitoring system Noninvasive haemodynamic monitoring system Noninvasive haemodynamic monitoring system Noninvasive haemodynamic monitoring system Noninvasive haemodynamic monitoring system Noninvasive haemodynamic monitoring system Noninvasive haemodynamic monitoring system Noninvasive haemodynamic monitoring system Noninvasive haemodynamic monitoring system Noninvasive haemodynamic monitoring system Noninvasive haemodynamic monitoring system

• Primary Device ID: 00860001506471
• NIH Device Record Key: 01939445-4021-4e30-ba33-80094042feb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Retia Medical
• Version Model Number: FG-008
• Company DUNS: 025675871
• Company Name: RETIA MEDICAL, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com
• Phone: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com
• Phone: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com
• Phone: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com
• Phone: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com
• Phone: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com
• Phone: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com
• Phone: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com
• Phone: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com
• Phone: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com
• Phone: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com
• Phone: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com
• Phone: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com
• Phone: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com
• Phone: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com
• Phone: (914) 594-1986
• Email: HAgashe@mkmventuresllc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001506471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181372

FDA Product Code

• DXG: Computer, Diagnostic, Pre-Programmed, Single-Function

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-13
• Device Publish Date: 2021-04-05

On-Brand Devices [Retia Medical]

• 00860001506402: The Argos Cardiac Output monitoring device is intended for use on patients above the age of 18.
• 00860001506457: Drager Interface Cable (14-pin MDR)
• 00860001506440: GE Interface Cable (7-pin Mini-DIN)
• 00860001506433: Transducer Interface Cable
• 00860001506426: GE Interface Cable (9-pin PDM)
• 00860001506419: Philips Interface Cable (3.5 mm Stereo Jack)
• 00860001506464: Spacelabs Interface Cable
• 00860001506471: Argos LAN Connectivity Kit
• 00860001506495: Argos Monitor Power Supply and AC Cord
• 00860001506488: Argos Serial Connectivity Kit
• 00850044487004: Mindray Interface Cable
• 00850044487011: Nihon Kohden Interface Cable