NaviStar NS7TCJL174HS
GUDID 10846835008586
BIOSENSE WEBSTER INC.
Cardiac radio-frequency ablation system catheter| Primary Device ID | 10846835008586 |
| NIH Device Record Key | c74e3c76-112f-42c3-b9c8-3cf4e9393e4c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NaviStar |
| Version Model Number | NS7TCJL174HS |
| Catalog Number | NS7TCJL174HS |
| Company DUNS | 020163218 |
| Company Name | BIOSENSE WEBSTER 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 | true |
| 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10846835008586 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P990025
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 | 4 |
| Public Version Date | 2021-06-28 |
| Device Publish Date | 2014-09-10 |
On-Brand Devices [NaviStar]
| 10846835008586 | NS7TCJL174HS |
| 10846835008579 | NS7TCEL174HS |
| 10846835008562 | NS7TCDM174HS |
| 10846835008555 | NS7TCCL174HS |
| 10846835008531 | NS7TCBL174HS |
| 10846835001990 | 118435S |
| 10846835001983 | 118434S |
| 10846835001976 | 118432S |
| 10846835001969 | 118431S |
| 10846835001952 | 118430S |
| 10846835001914 | 118332S |
| 10846835001907 | 118331S |
| 10846835001891 | 118330S |
| 10846835000610 | NS7TCFL174HS |
| 10846835000597 | NS7TCDL174HS |
Trademark Results [NaviStar]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NAVISTAR 85716320 4427688 Live/Registered |
NAVISTAR INTERNATIONAL CORPORATION 2012-08-29 |
 NAVISTAR 85565255 not registered Dead/Abandoned |
Aetrex Worldwide, Inc. 2012-03-09 |
 NAVISTAR 85480167 4307559 Dead/Cancelled |
NORTHROP GRUMMAN SPERRY MARINE B.V. 2011-11-23 |
 NAVISTAR 77207365 3651780 Live/Registered |
Navistar International Corporation 2007-06-15 |
 NAVISTAR 76474075 3018943 Dead/Cancelled |
NORTHROP GRUMMAN SPERRY MARINE B.V. 2002-12-12 |
 NAVISTAR 74437137 1873751 Dead/Cancelled |
NAVISTAR INTERNATIONAL CORPORATION 1993-09-15 |
 NAVISTAR 73670598 1474900 Dead/Cancelled |
NAVISTAR INTERNATIONAL CORPORATION 1987-07-06 |
 NAVISTAR 73660859 not registered Dead/Abandoned |
NAVISTAR INTERNATIONAL CORPORATION 1987-05-14 |
 NAVISTAR 73586422 1472594 Live/Registered |
NAVISTAR INTERNATIONAL CORPORATION 1986-03-06 |
 NAVISTAR 73586421 1476173 Live/Registered |
NAVISTAR INTERNATIONAL CORPORATION 1986-03-06 |
 NAVISTAR 73581082 1495860 Dead/Cancelled |
INTERNATIONAL HARVESTER COMPANY 1986-02-03 |
 NAVISTAR 73572790 1498530 Live/Registered |
INTERNATIONAL HARVESTER COMPANY 1985-12-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.