SENSIMED Triggerfish® Recorder

Basic Information

• Brand Name: SENSIMED Triggerfish® Recorder
• Primary DI: 07640153470133
• Version / Model: R.V.4.1
• Catalog Number: ST5000
• 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: 4
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: 57e90d2a-2442-47c8-b5e9-73314d213be7

Device Description

A small, battery operated electronic device that is used to operate the SENSIMED Triggerfish® Sensor and store the obtained data

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: MR Unsafe
• 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
PLZ	Ocular Pattern Recorder	Ophthalmic	886.1925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62113	Ocular volume ambulatory recording system recorder	An electrically-powered component of an ocular volume ambulatory recording system intended to be used during daily activities and sleep (e.g., by patients at risk of glaucoma progression) to record data acquired by a sensor and transmitted by a transceiver. Recorded data is analysed and displayed by an off-the-shelf computing device (e.g., laptop) using dedicated software, to indicate patterns of intraocular pressure (IOP) fluctuation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640153470133	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN140017	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 20.67 – 31.3 Inches of Mercury
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 23.62 – 31.3 Inches of Mercury