SENSIMED Triggerfish® Software ST8000

GUDID 07640153470157

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

Sensimed SA

Ocular volume ambulatory recording system software

• Primary Device ID: 07640153470157
• NIH Device Record Key: ab0eb009-0b09-457c-bc41-14773698ae2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SENSIMED Triggerfish® Software
• Version Model Number: V3
• Catalog Number: ST8000
• Company DUNS: 482491177
• Company Name: Sensimed SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41216219191
• Email: info@sensimed.ch

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640153470157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN140017

FDA Product Code

• PLZ: Ocular Pattern Recorder

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-20

Devices Manufactured by Sensimed SA

• 07640153470126 - SENSIMED Triggerfish® Recorder Sleeve: 2019-12-11 A box of ten SENSIMED Triggerfish® Recorder Sleeve
• 07640153470133 - SENSIMED Triggerfish® Recorder: 2019-11-08 A small, battery operated electronic device that is used to operate the SENSIMED Triggerfish® Sensor and store the obtained dat
• 07640153470010 - SENSIMED Triggerfish® Sensor STEEP: 2018-07-06 A single unit of STEEP SENSIMED Triggerfish® Sensor
• 07640153470027 - SENSIMED Triggerfish® Sensor MEDIUM: 2018-07-06 A single unit of MEDIUM SENSIMED Triggerfish® Sensor
• 07640153470034 - SENSIMED Triggerfish® Sensor FLAT: 2018-07-06 A single unit of FLAT SENSIMED Triggerfish® Sensor
• 07640153470041 - SENSIMED Triggerfish® Sensor STEEP: 2018-07-06 A box of three STEEP SENSIMED Triggerfish® Sensors
• 07640153470058 - SENSIMED Triggerfish® Sensor MEDIUM: 2018-07-06 A box of three MEDIUM SENSIMED Triggerfish® Sensors
• 07640153470065 - SENSIMED Triggerfish® Sensor FLAT: 2018-07-06 A box of three FLAT SENSIMED Triggerfish® Sensors