OptoMonitor

Basic Information

• Brand Name: OptoMonitor
• Primary DI: 07540184020201
• Version / Model: Display Unit
• Catalog Number: F2020
• Company Name: Opsens Inc
• Labeler DUNS: 253717946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2024-05-03
• Public Version Status: Update
• Public Device Record Key: 65c322cc-98d2-431a-9b15-178ed2867317

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQX	Wire, Guide, Catheter	Cardiovascular	870.1330	2
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	870.2870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36612	Image display unit, colour	An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540184020201	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K142598	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry