TYSHAK X™ 618321
GUDID 04046964313509
TYSHAK-X 14X4X8X7X100X.035 PDC321
B BRAUN INTERVENTIONAL SYSTEMS, INC
Cardiac valvuloplasty catheter| Primary Device ID | 04046964313509 |
| NIH Device Record Key | 1c1b9d9d-9021-41f6-a199-76284168042b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TYSHAK X™ |
| Version Model Number | 618321 |
| Catalog Number | 618321 |
| Company DUNS | 784259751 |
| Company Name | B BRAUN INTERVENTIONAL SYSTEMS, 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964313509 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K022722
FDA Product Code
| DQY | CATHETER, PERCUTANEOUS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-04-07 |
| Device Publish Date | 2016-08-09 |
On-Brand Devices [TYSHAK X™]
| 04046964314032 | TYSHAK-X 25X6X11X9X100X.035 PDC347 |
| 04046964314018 | TYSHAK-X 25X5X11X9X100X.035 PDC346 |
| 04046964313998 | TYSHAK-X 25X4X11X9X100X.035 PDC345 |
| 04046964313974 | TYSHAK-X 25X3X11X9X100X.035 PDC344 |
| 04046964313950 | TYSHAK-X 22X6X10X9X100X.035 PDC343 |
| 04046964313936 | TYSHAK-X 22X5X10X9X100X.035 PDC342 |
| 04046964313912 | TYSHAK-X 22X4X10X9X100X.035 PDC341 |
| 04046964313899 | TYSHAK-X 22X3X10X9X100X.035 PDC340 |
| 04046964313875 | TYSHAK-X 20X6X10X8X100X.035 PDC339 |
| 04046964313851 | TYSHAK-X 20X5X10X8X100X.035 PDC338 |
| 04046964313837 | TYSHAK-X 20X4X10X8X100X.035 PDC337 |
| 04046964313813 | TYSHAK-X 20X3X10X8X100X.035 PDC336 |
| 04046964313790 | TYSHAK-X 18X6X9X8X100X.035 PDC335 |
| 04046964313776 | TYSHAK-X 18X5X9X8X100X.035 PDC334 |
| 04046964313752 | TYSHAK-X 18X4X9X8X100X.035 PDC333 |
| 04046964313721 | TYSHAK-X 18X3X9X8X100X.035 PDC332 |
| 04046964313707 | TYSHAK-X 16X6X8X7X100X.035 PDC331 |
| 04046964313684 | TYSHAK-X 16X5X8X7X100X.035 PDC330 |
| 04046964313660 | TYSHAK-X 16X4X8X7X100X.035 PDC329 |
| 04046964313646 | TYSHAK-X 16X3X8X7X100X.035 PDC328 |
| 04046964313622 | TYSHAK-X 15X6X8X7X100X.035 PDC327 |
| 04046964313608 | TYSHAK-X 15X5X8X7X100X.035 PDC326 |
| 04046964313585 | TYSHAK-X 15X4X8X7X100X.035 PDC325 |
| 04046964313561 | TYSHAK-X 15X3X8X7X100X.035 PDC324 |
| 04046964313547 | TYSHAK-X 14X6X8X7X100X.035 PDC323 |
| 04046964313523 | TYSHAK-X 14X5X8X7X100X.035 PDC322 |
| 04046964313509 | TYSHAK-X 14X4X8X7X100X.035 PDC321 |
| 04046964313486 | TYSHAK-X 14X3X8X7X100X.035 PDC320 |
| 04046964313462 | TYSHAK-X 12X6X7X6X100X.035 PDC319 |
| 04046964313448 | TYSHAK-X 12X5X7X6X100X.035 PDC318 |
| 04046964313424 | TYSHAK-X 12X4X7X6X100X.035 PDC317 |
| 04046964313400 | TYSHAK-X 12X3X7X6X100X.035 PDC316 |
| 04046964313387 | TYSHAK-X 12X2X7X6X100X.035 PDC315 |
| 04046964313363 | TYSHAK-X 10X6X6X6X100X.035 PDC314 |
| 04046964313349 | TYSHAK-X 10X5X6X6X100X.035 PDC313 |
| 04046964313325 | TYSHAK-X 10X4X6X6X100X.035 PDC312 |
| 04046964313301 | TYSHAK-X 10X3X6X6X100X.035 PDC311 |
| 04046964313288 | TYSHAK-X 10X2X6X6X100X.035 PDC310 |
| 04046964313264 | TYSHAK-X 9X6X6X6X100X.035 PDC309 |
| 04046964313240 | TYSHAK-X 9X5X6X6X100X.035 PDC308 |
| 04046964313226 | TYSHAK-X 9X4X6X6X100X.035 PDC307 |
| 04046964313202 | TYSHAK-X 9X3X6X6X100X.035 PDC306 |
| 04046964313189 | TYSHAK-X 9X2X6X6X100X.035 PDC305 |
| 04046964313158 | TYSHAK-X 8X6X6X6X100X.035 PDC304 |
| 04046964313134 | TYSHAK-X 8X5X6X6X100X.035 PDC303 |
| 04046964313127 | TYSHAK-X 8X4X6X6X100X.035 PDC302 |
| 04046964313097 | TYSHAK-X 8X3X6X6X100X.035 PDC301 |
| 04046964313073 | TYSHAK-X 8X2X6X6X100X.035 PDC300 |
Trademark Results [TYSHAK X]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TYSHAK X 78179506 2803769 Dead/Cancelled |
NuMED, Inc. 2002-10-29 |
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