RF ENHANCR® II
GUDID 00643169147928
CATH 31745523 RF ENHANCR II W/O CE
MEDTRONIC, INC.
Cardiac radio-frequency ablation system catheter| Primary Device ID | 00643169147928 |
| NIH Device Record Key | f92b3780-d15f-42d5-b0ca-faebfc07c091 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RF ENHANCR® II |
| Version Model Number | 31745523 |
| 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 | true |
| 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 | true |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169147928 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P930029
FDA Product Code
| LPB | Cardiac ablation percutaneous catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-23 |
On-Brand Devices [RF ENHANCR® II]
| 00643169147980 | CATH 39746534 RF ENHANCR II W/O CE |
| 00643169147966 | CATH 39745533 RF ENHANCR II W/O CE |
| 00643169147942 | CATH 31745533 RF ENHANCR II W/O CE |
| 00643169147928 | CATH 31745523 RF ENHANCR II W/O CE |
| 00643169147904 | CATH 31744523 RF ENHANCR II W/O CE |
Trademark Results [RF ENHANCR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RF ENHANCR 78057650 2698775 Live/Registered |
MEDTRONIC INC. 2001-04-10 |
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