Retia Medical

GUDID 00860001506464

Spacelabs Interface Cable

RETIA MEDICAL, LLC

Noninvasive haemodynamic monitoring system

• Primary Device ID: 00860001506464
• NIH Device Record Key: 299e30ca-988a-48ad-a0e5-2daed45fb414
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Retia Medical
• Version Model Number: FG-007
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001506464 [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: 2020-04-20
• Device Publish Date: 2020-04-10

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