Cardioblate® CryoFlex™
GUDID 00643169183827
ACCY 65TC1 CRYOFLEX TANK CARRIER
MEDTRONIC, INC.
General cryosurgical system, cryogen gas, mechanical| Primary Device ID | 00643169183827 |
| NIH Device Record Key | 7808288a-b256-4ecf-8018-6e6e699b968c |
| Commercial Distribution Status | 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 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| 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 *Storage and Operating Humidity: 10% to 95%, noncondensing |
| 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 Shipping Temperature: -40°C to 66°C (-40°F to 150°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing |
| 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 Shipping Temperature: -40°C to 66°C (-40°F to 150°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing |
| 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 Shipping Temperature: -40°C to 66°C (-40°F to 150°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing |
| 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 Shipping Temperature: -40°C to 66°C (-40°F to 150°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing |
| 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 Shipping Temperature: -40°C to 66°C (-40°F to 150°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing |
| 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 Shipping Temperature: -40°C to 66°C (-40°F to 150°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing |
| 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 Shipping Temperature: -40°C to 66°C (-40°F to 150°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing |
| 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 Shipping Temperature: -40°C to 66°C (-40°F to 150°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing |
| 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 Shipping Temperature: -40°C to 66°C (-40°F to 150°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing |
| 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 Shipping Temperature: -40°C to 66°C (-40°F to 150°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing |
| 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 Shipping Temperature: -40°C to 66°C (-40°F to 150°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing |
| 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 Shipping Temperature: -40°C to 66°C (-40°F to 150°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing |
| 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 Shipping Temperature: -40°C to 66°C (-40°F to 150°F) |
| Special Storage Condition, Specify | Between 0 and 0 *Storage and Operating Humidity: 10% to 95%, noncondensing |
| 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 Shipping Temperature: -40°C to 66°C (-40°F to 150°F) |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169183827 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121878
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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-29 |
On-Brand Devices [Cardioblate® CryoFlex™]
| 00613994959454 | ACCY 65TC1 CRYOFLEX TANK CARRIER EN |
| 00643169183827 | ACCY 65TC1 CRYOFLEX TANK CARRIER |
Trademark Results [Cardioblate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDIOBLATE 78264538 2875737 Live/Registered |
Medtronic, Inc. 2003-06-19 |
 CARDIOBLATE 76017616 2672681 Dead/Cancelled |
Medtronic, Inc. 2000-03-29 |
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