TYSHAK II® 611781
GUDID 04046964337895
SO021 TYSHAK II 6 X 3
B BRAUN INTERVENTIONAL SYSTEMS, INC
Cardiac valvuloplasty catheter| Primary Device ID | 04046964337895 |
| NIH Device Record Key | a415936a-a92f-4026-825c-40c4d915db07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TYSHAK II® |
| Version Model Number | 611781 |
| Catalog Number | 611781 |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964337895 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K003052
FDA Product Code
| LIT | Catheter, angioplasty, peripheral, transluminal |
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 II®]
| 04046964339615 | PDC550 TYSHAK II 30 X 6 SP |
| 04046964339592 | PDC549 TYSHAK II 30 X 5 SP |
| 04046964339578 | PDC548 TYSHAK II 30 X 4 SP |
| 04046964339554 | PDC547 TYSHAK II 30 X 3 SP |
| 04046964339530 | PDC546 25MM X 6CM BALL CATH TYSHA II STD |
| 04046964339516 | PDC545 25MM X 5CM BALL CATH TYSHA II STD |
| 04046964339493 | PDC544 25MM X 4CM BALL CATH TYSHA II STD |
| 04046964339479 | PDC543 TYSHAK II 25 X 3 SP |
| 04046964339455 | PDC542 TYSHAK II 23 X 6 SP |
| 04046964339431 | PDC541 23MM X 5CM BALL CATH TYSHA II STD |
| 04046964339417 | PDC540 23MM X 4CM BALL CATH TYSHA II STD |
| 04046964339394 | PDC539 TYSHAK II 23 X 3 SP |
| 04046964339370 | PDC538 22MM X 6CM BALL CATH TYSHA II STD |
| 04046964339356 | PDC537 22MM X 5CM BALL CATH TYSHA II STD |
| 04046964339332 | PDC536 22MM X 4CM BALL CATH TYSHA II STD |
| 04046964339318 | PDC535 TYSHAK II 22 X 3 SP |
| 04046964339295 | PDC534 20MM X 6CM BALL CATH TYSHA II STD |
| 04046964339271 | PDC533 20MM X 5CM BALL CATH TYSHA II STD |
| 04046964339257 | PDC532 20MM X 4CM BALL CATH TYSHA II STD |
| 04046964339233 | PDC531 20MM X 3CM BALL CATH TYSHA II STD |
| 04046964339219 | PDC530 18MM X 6CM BALL CATH TYSHA II STD |
| 04046964339202 | PDC529 18MM X 5CM BALL CATH TYSHA II STD |
| 04046964339172 | PDC528 TYSHAK II 18 X 4 STD |
| 04046964339158 | PDC527 18MM X 3CM BALL CATH TYSHA II STD |
| 04046964339141 | PDC526 TYSHAK II 17 X 6 SP |
| 04046964339127 | PDC525 TYSHAK II 17 X 5 SP |
| 04046964339097 | PDC524 TYSHAK II 17 X 4 SP |
| 04046964339080 | PDC523 TYSHAK II 17 X 3 SP |
| 04046964339059 | PDC522 TYSHAK II 16 X 6 SP |
| 04046964339035 | PDC521 16MM X 5CM BALL CATH TYSHA II STD |
| 04046964339011 | PDC520 16MM X 4CM BALL CATH TYSHA II STD |
| 04046964339004 | PDC519 TYSHAK II 16 X 3 STD |
| 04046964338953 | PDC517 15MM X 5CM BALL CATH TYSHA II STD |
| 04046964338946 | PDC516 15MM X 4CM BALL CATH TYSHA II STD |
| 04046964338922 | PDC515 15MM X 3CM BALL CATH TYSHA II STD |
| 04046964338908 | PDC514 TYSHAK II 14 X 6 SP |
| 04046964338885 | PDC513 TYSHAK II 14 X 5 SP |
| 04046964338861 | PDC512 TYSHAK II 14 X 4 STD |
| 04046964338847 | PDC511 TYSHAK II 14 X 3 STD |
| 04046964338823 | SO008 12MM X 2CM BALL CATH TYSHAK II STD |
| 04046964338809 | SO003 10MM X 2CM BALL CATH TYSHAK II STD |
| 04046964338786 | SO007 TYSHAK II 9MM 2CM STD |
| 04046964338205 | SO038 TYSHAK II 17MM 8CM |
| 04046964338182 | SO037 TYSHAK II 16MM 8CM SP |
| 04046964338168 | SO036 TYSHAK II 13MM 3CM SP |
| 04046964338144 | SO035 TYSHAK II 13MM 2CM SP |
| 04046964338120 | SO034 TYSHAK II 13MM 4CM SP |
| 04046964338106 | SO033 TYSHAK II 12MM 5CM SP |
| 04046964338083 | SO032 TYSHAK II 8MM 5CM SP |
| 04046964338069 | SO031 Z-MED TYSHAK II 10MM 5CM |
Trademark Results [TYSHAK II]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TYSHAK II 75284745 2186876 Live/Registered |
NuMED, INC. 1997-05-01 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.