OptoMonitor 3 F232011

GUDID 07540184020119

Opsens Inc

Cardiac catheterization laboratory computer

• Primary Device ID: 07540184020119
• NIH Device Record Key: 0b995237-5e42-4516-b84b-8d9f4e4601a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptoMonitor 3
• Version Model Number: OpM3-OU Power Supply Cable
• Catalog Number: F232011
• 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	07540184020119 [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