Cardioblate® CryoFlex™

GUDID 00613994959454

ACCY 65TC1 CRYOFLEX TANK CARRIER EN

MEDTRONIC, INC.

General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 00613994959454
• NIH Device Record Key: d0a4e234-bb9f-488a-9242-66d1f22607e8
• Commercial Distribution Discontinuation: 2018-10-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cardioblate® CryoFlex™
• Version Model Number: 65TC1
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)
• Special Storage Condition, Specify: Between 0 and 0 *Operating Temperature: 10°C to 44°C (50°F to 110°F) at altitudes ranging from sea level to 3000 meters (10,000 feet)
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage and Shipping Temperature: -40°C to 66°C (-40°F to 150°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994959454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053436

FDA Product Code

• OCL: Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-19
• Device Publish Date: 2016-09-29

On-Brand Devices [Cardioblate® CryoFlex™]

• 00613994959454: ACCY 65TC1 CRYOFLEX TANK CARRIER EN
• 00643169183827: ACCY 65TC1 CRYOFLEX TANK CARRIER