EsoFLIP

GUDID 05391530810159

EsoFLIP Dilation Catheter for use with EndoFLIP System

CROSPON LIMITED

Gastrointestinal/biliary dilation balloon catheter

• Primary Device ID: 05391530810159
• NIH Device Record Key: 3476681c-f63b-4c38-9144-ca7fa8e1d127
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EsoFLIP
• Version Model Number: ES-310
• 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

Device Dimensions

• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 Millimeter
• Outer Diameter: 20 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391530810135 [Primary]
GS1	05391530810159 [Package]; Contains: 05391530810135; Package: Box [5 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-24
• Device Publish Date: 2020-04-16

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