Cardioblate® CryoFlex®
GUDID 00643169183759
REGULATOR 67RAXNA CRYOFLEX NA
MEDTRONIC, INC.
General cryosurgical system, cryogen gas, mechanical| Primary Device ID | 00643169183759 |
| NIH Device Record Key | 2d74bbc6-e8a3-4063-9a73-03eba2a66923 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cardioblate® CryoFlex® |
| Version Model Number | 67RAXNA |
| 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 | false |
| Serial Number | true |
| 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
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169183759 [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 | 2016-05-02 |
On-Brand Devices [Cardioblate® CryoFlex®]
| 00643169305106 | CLAMP 60CM1 CRYOFLEX PROBE 26L |
| 00643169183889 | PROBE 60SF2 CRYOFLEX 10CM 26L |
| 00643169183865 | PROBE 60SF3 CRYOFLEX 10CM 26L |
| 00643169183841 | PROBE 60SF7 CRYOFLEX 10CM 26L |
| 00643169183834 | CONSOLE 65CS1 CRYOFLEX 26L |
| 00643169183759 | REGULATOR 67RAXNA CRYOFLEX NA |
| 00763000114640 | CLAMP 60CM1 CRYOFLEX PROBE 26L |
| 00763000114633 | PROBE 60SF7 CRYOFLEX 7CM 26L |
| 00763000114626 | PROBE 60SF3 CRYOFLEX 10-S 26L |
| 00763000114619 | PROBE 60SF2 CRYOFLEX 10CM 26L |
| 00763000014995 | REGULATOR 67RAXE-006 CRYOFLEX NON-ROHS |
| 00763000014988 | CONSOLE 65CS1-006 CRYOFLEX NON-ROHS |
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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