EndoFLIP

GUDID 05391530810142

FLIP Topography Module

CROSPON LIMITED

Oesophageal motility analysis system

• Primary Device ID: 05391530810142
• NIH Device Record Key: 2a7ff776-d269-4a9f-8cd8-85d2b053029c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoFLIP
• Version Model Number: DD-961
• Company DUNS: 989779517
• Company Name: CROSPON LIMITED
• 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: false
• Lot Batch: false
• Serial Number: true
• 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: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com
• Phone: 8582767766
• Email: info@crospon.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 160 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391530810142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170833

FDA Product Code

• FFX: System, Gastrointestinal Motility (Electrical)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-06-24

On-Brand Devices [EndoFLIP]

• 05391530810142: FLIP Topography Module
• 05391530810050: EndoFLIP System
• 05391530810029: EndoFLIP Measurement Catheter for use with EndoFLIP System
• 05391530810012: EndoFLIP Measurement Catheter for use with EndoFLIP System
• 05391530810005: EndoFLIP Measurement Catheter for use with EndoFLIP System