SENSIMED Triggerfish® Software

Basic Information

• Brand Name: SENSIMED Triggerfish® Software
• Primary DI: 07640153470157
• Version / Model: V3
• Catalog Number: ST8000
• Company Name: Sensimed SA
• Labeler DUNS: 482491177
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ab0eb009-0b09-457c-bc41-14773698ae2c

Device Description

Computer software for the configuration of SENSIMED Triggerfish® monitoring session and subsequent downloading, display and analysis of data from these sessions

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
PLZ	Ocular Pattern Recorder	Ophthalmic	886.1925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62114	Ocular volume ambulatory recording system software	A software program intended to display and analyse recorded data produced by an ocular volume ambulatory recording system, to indicate patterns of intraocular pressure (IOP) fluctuation (e.g., to support patients at risk of glaucoma progression).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640153470157	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN140017	000