SENSIMED Triggerfish® Sensor FLAT ST1003

GUDID 07640153470034

A single unit of FLAT SENSIMED Triggerfish® Sensor

Sensimed SA

Ocular volume ambulatory recording system sensor

• Primary Device ID: 07640153470034
• NIH Device Record Key: bcdc02b1-8a60-4c7f-8fe6-a4e1c09c3d29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SENSIMED Triggerfish® Sensor FLAT
• Version Model Number: F.V.4
• Catalog Number: ST1003
• Company DUNS: 482491177
• Company Name: Sensimed SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Outer Diameter: 14.1 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640153470034 [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: true

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

On-Brand Devices [SENSIMED Triggerfish® Sensor FLAT]

• 07640153470065: A box of three FLAT SENSIMED Triggerfish® Sensors
• 07640153470034: A single unit of FLAT SENSIMED Triggerfish® Sensor