Cardioblate® CryoFlex™
GUDID 00643169183827
ACCY 65TC1 CRYOFLEX TANK CARRIER
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 | 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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