TORQR®
GUDID 00613994947451
CATH 04122JM TORQR USA 5FR, W/O CE
MEDTRONIC, INC.
Cardiac mapping catheter, percutaneous, single-use| Primary Device ID | 00613994947451 |
| NIH Device Record Key | 835147a1-71ef-4396-ac91-ff2a9622f1cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TORQR® |
| Version Model Number | 04122JM |
| 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| 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 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994947451 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K923915
FDA Product Code
| DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-04-03 |
On-Brand Devices [TORQR®]
| 00613994947536 | CATH 041890CS TORQR USA CS W/O CE |
| 00613994947529 | CATH 041865CS TORQR USA CS W/O CE |
| 00613994947512 | CATH 041590CS TORQR USA CS W/O CE |
| 00613994947505 | CATH 041565CS TORQR USA CS W/O CE |
| 00613994947499 | CATH 04130DS TORQR USA 5FR W/O CE |
| 00613994947482 | CATH 04125UM TORQR USA 5FR W/O CE |
| 00613994947475 | CATH 04125JM TORQR USA 5FR W/O CE |
| 00613994947468 | CATH 04122UM TORQR USA 5FR W/O CE |
| 00613994947451 | CATH 04122JM TORQR USA 5FR, W/O CE |
| 00613994947437 | CATH 041010UM TORQR USA MKT 6FR W/O CE |
| 00613994947420 | CATH 041010JM TORQR USA MKT 6FR W/O CE |
| 00613994947413 | CATH 041005UM TORQR USA 6FR W/O CE |
| 00613994947406 | CATH 041005JM TORQR USA 6FR W/O CE |
| 00613994947390 | CATH 041005DM TORQR USA 6FR W/O CE |
| 00613994947383 | CATH 041002UM TORQR USA MKT 6FR W/O CE |
| 00613994947376 | CATH 041002JM TORQR USA MKT 6FR W/O CE |
Trademark Results [TORQR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TORQR 78050993 2606023 Dead/Cancelled |
MEDTRONIC, INC. 2001-03-02 |
 TORQR 74251158 1782085 Dead/Cancelled |
CardioRhythm 1992-03-02 |
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