OptoMonitor 3 F232012

GUDID 07540184020126

Opsens Inc

Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer Cardiac catheterization laboratory computer

• Primary Device ID: 07540184020126
• NIH Device Record Key: 1f899b77-03e9-46fa-a6fb-a3125499faf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptoMonitor 3
• Version Model Number: OpM3-DU Power Supply Cable
• Catalog Number: F232012
• Company DUNS: 253717946
• Company Name: Opsens Inc
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540184020126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193620

FDA Product Code

• DXO: Transducer, Pressure, Catheter Tip

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: 2020-07-28
• Device Publish Date: 2020-07-20

On-Brand Devices [OptoMonitor 3]

• 07540184132010: OpM3 OU-DU LAN Cable
• 07540184023301: OpM3 Handle Unit
• 07540184023219: OpM3 Display Unit 15"
• 07540184023202: OpM3 Display Unit 10"
• 07540184023103: OpM3 Optical Unit
• 07540184020126: OpM3-DU Power Supply Cable
• 07540184020119: OpM3-OU Power Supply Cable
• 07540184020096: OpM3 OU-DU RS-232 comm cable