SENSIMED Triggerfish® Antenna RIGHT ST2002

GUDID 07640153470096

A single unit of SENSIMED Triggerfish® eye patch antenna for use around the right eye

Sensimed SA

Ocular monitoring/recording system ambulatory antenna, single-use

• Primary Device ID: 07640153470096
• NIH Device Record Key: 253ed63a-7da7-4c8a-94a3-d794f53142b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SENSIMED Triggerfish® Antenna RIGHT
• Version Model Number: AR.3
• Catalog Number: ST2002
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

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	07640153470096 [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

On-Brand Devices [SENSIMED Triggerfish® Antenna RIGHT]

• 07640153470119: A box of three SENSIMED Triggerfish® eye patch antennae for use around the right eye
• 07640153470096: A single unit of SENSIMED Triggerfish® eye patch antenna for use around the right eye