C2 CryoBalloon Focal Pear Catheter FG-1033

GUDID 00854924006330

C2 CryoBalloon Focal Pear Catheter for C2 CryoBalloon Ablation System

C2 THERAPEUTICS, INC.

Gastrointestinal/biliary dilation balloon catheter

• Primary Device ID: 00854924006330
• NIH Device Record Key: 6ccd553e-8514-4a26-b911-c8f763875f45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C2 CryoBalloon Focal Pear Catheter
• Version Model Number: FG-1033
• Catalog Number: FG-1033
• Company DUNS: 929139249
• Company Name: C2 THERAPEUTICS, INC.
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854924006330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160994

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

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: 2016-10-19

Devices Manufactured by C2 THERAPEUTICS, INC.

• 00854924006118 - Sidecar External Working Channel: 2018-07-06 Sidecar External Working Channel, Endoscopic Accessory
• 00854924006163 - BOA Endoscopic Valve: 2018-07-06 BOA Endoscopic Valve, Endoscopic Accessory
• 00854924006170 - C2 CryoBalloon: 2018-07-06 Controller
• 00854924006187 - C2 CryoBalloon: 2018-07-06 Foot Pedal
• 00854924006323 - C2 CryoBalloon Full 8 Catheter: 2018-07-06 C2 CryoBalloon Full 8 Catheter for C2 CryoBalloon Ablation System
• 00854924006330 - C2 CryoBalloon Focal Pear Catheter: 2018-07-06C2 CryoBalloon Focal Pear Catheter for C2 CryoBalloon Ablation System
• 00854924006330 - C2 CryoBalloon Focal Pear Catheter: 2018-07-06 C2 CryoBalloon Focal Pear Catheter for C2 CryoBalloon Ablation System
• 00854924006248 - C2 CryoBalloon: 2018-04-26 Pear Catheter Focal
• 00854924006262 - C2 CryoBalloon: 2018-04-26 90 Pear Catheter