SENSIMED Triggerfish® Sensor FLAT

Basic Information

• Brand Name: SENSIMED Triggerfish® Sensor FLAT
• Primary DI: 07640153470034
• Version / Model: F.V.4
• Catalog Number: ST1003
• 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: bcdc02b1-8a60-4c7f-8fe6-a4e1c09c3d29

Device Description

A single unit of FLAT SENSIMED Triggerfish® Sensor

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
62111	Ocular volume ambulatory recording system sensor	A sterile, electronic component of an ambulatory ocular volume recording system which is in the form of a contact lens containing a sensor designed to measure and transmit variations in ocular volume (i.e., circumferential changes at the corneoscleral area), to indicate patterns of intraocular pressure (IOP) fluctuation. It is worn during daily activities and sleep (e.g., by patients at risk of glaucoma progression). It is powered by and wirelessly communicates with a patient-worn transceiver which is connected to a recorder. Recorded data is displayed and analysed by an off-the-shelf computing device (e.g., laptop) using dedicated software. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640153470034	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN140017	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	14.1	Millimeter

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