EsoFLIP

GUDID 05391530810043

EsoFLIP Dilation Catheter for use with EndoFLIP System

CROSPON LIMITED

Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter Gastrointestinal/biliary dilation balloon catheter

• Primary Device ID: 05391530810043
• NIH Device Record Key: 6f9e84bf-0dc1-4844-8dc9-7039110a7399
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EsoFLIP
• Version Model Number: ES-330
• Company DUNS: 989779517
• Company Name: CROSPON LIMITED
• 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: 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: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com
• Phone: 8552767766
• Email: info@crospon.com

Device Dimensions

• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391530810043 [Primary]
GS1	05391530810098 [Package]; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132337

FDA Product Code

• PIE: Esophageal Dilator With Balloon And Electrode Sensors

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: 2016-08-02

On-Brand Devices [EsoFLIP]

• 05391530810043: EsoFLIP Dilation Catheter for use with EndoFLIP System
• 05391530810036: EsoFLIP Dilation Catheter for use with EndoFLIP System
• 05391530810159: EsoFLIP Dilation Catheter for use with EndoFLIP System