SENSIMED Triggerfish® Sensor SMF BO3SMF

GUDID 07640153470072

A box of one STEEP, one MEDIUM and one FLAT SENSIMED Triggerfish® Sensors

Sensimed SA

Ocular volume ambulatory recording system sensor

• Primary Device ID: 07640153470072
• NIH Device Record Key: 13ed6b33-3828-4bdf-ae5a-2e2e1043f895
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SENSIMED Triggerfish® Sensor SMF
• Version Model Number: SMF.V.4
• Catalog Number: BO3SMF
• 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: false
• 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	07640153470072 [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

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