TYSHAK® 610500
GUDID 04046964329524
PDC001 4MM X 1CM BALLOON CATH TYSHAK SP
B BRAUN INTERVENTIONAL SYSTEMS, INC
Cardiac valvuloplasty catheter| Primary Device ID | 04046964329524 |
| NIH Device Record Key | 5b6704c0-0fbd-4e87-b8d8-add18bdb4c07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TYSHAK® |
| Version Model Number | 610500 |
| Catalog Number | 610500 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964329524 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K931009
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 | 4 |
| Public Version Date | 2022-11-02 |
| Device Publish Date | 2016-08-09 |
On-Brand Devices [TYSHAK®]
| 04046964335501 | SO010 TYSHAK 13MM 3CM |
| 04046964335150 | PDC095 TYSHAK 15MM 2CM |
| 04046964333750 | PDC098 TYSHAK 13MM 5CM |
| 04046964333613 | PDC082 SP BALL CATH 25MM 5.5CM TYSHAK |
| 04046964331800 | PDC139 SPECIAL BALLOON CATH 22MM 6CM |
| 04046964331671 | PDC148 SPECIAL BALLOON CATH 12MM 2CM |
| 04046964330995 | PDC076 SPECIAL BALLOON CATH 18MM 4CM |
| 04046964330971 | PDC069 SPECIAL BALLOON CATH 8MM 8CM |
| 04046964330582 | PDC088 SPECIAL BALLOON CATH 6MM 2CM |
| 04046964330544 | PDC117 10MM X 3CM BALL CATH TYSHAK STD |
| 04046964329876 | PDC008 8MM X 3CM BALLOON CATH TYSHAK SP |
| 04046964329807 | PDC037 7MM X 4CM BALLOON CATH TYSHAK SP |
| 04046964332142 | PDC125 SPECIAL BALLOON CATH 16MM 9CM |
| 04046964332012 | PDC107 SPECIAL BALLOON CATH 14MM 4CM |
| 04046964331824 | PDC136 SPECIAL BALLOON CATH 19MM 6CM |
| 04046964555060 | PDC144 SPECIAL BALLOON CATH 16MM 6CM |
| 04046964335587 | SO015 BALLOON CATH SPEC TYSHAK 12MM 10C |
| 04046964335549 | SO012 TYSHAK BALLOON CATH 17MM 5CM |
| 04046964335105 | PDC157 SPEC BALLOON CATH TYSHAK 7MM 3C |
| 04046964334986 | PDC153 SPEC BALLOON CATH TYSHAK 14MM 5C |
| 04046964333798 | PDC100 SP BALLOON CATH 20MM 9CM TYSHAK |
| 04046964333774 | PDC099 SP BALLOON CATH 19MM 9CM TYSHAK |
| 04046964333736 | PDC097 SP BALLOON CATH 18MM 4CM TYSHAK |
| 04046964333699 | PDC087 SP BALLOON CATH 6MM 4CM TYSHAK |
| 04046964333637 | PDC083 SP BALL CATH 22MM 5.5CM TYSHAK |
| 04046964333583 | PCD065 SP BALLOON CATH 22MM 3CM TYSHAK |
| 04046964333576 | PDC050 SP BALLOON CATH 6MM 6CM TYSHAK |
| 04046964332203 | PDC128 SPECIAL BALLOON CATH 15MM 4CM |
| 04046964332166 | PDC126 SPECIAL BALLOON CATH 7MM 2CM |
| 04046964332135 | PDC124 SPECIAL BALLOON CATH 7MM 2CM |
| 04046964332111 | PDC123 SPECIAL BALLOON CATH 17MM 8CM |
| 04046964332081 | PDC122 SPECIAL BALLOON CATH 18MM 4CM |
| 04046964332074 | PDC121 SPECIAL BALLOON CATH 15MM 7CM |
| 04046964332029 | PDC108 SPECIAL BALLOON CATH 22MM 5.5CM |
| 04046964331978 | PDC130 SPECIAL BALLOON CATH 10MM 3CM |
| 04046964331954 | PDC134 SPECIAL BALLOON CATH 12MM 4CM |
| 04046964331930 | PDC133 SPECIAL BALLOON CATH 12MM 3CM |
| 04046964331879 | PDC132 SPECIAL BALLOON CATH 10MM 5CM |
| 04046964331848 | PDC138 SP BALLOON CATH 4MM 2CM TYSHAK |
| 04046964331787 | PDC141 SPECIAL BALLOON CATH 4MM 3CM |
| 04046964331749 | PDC143 SPECIAL BALLOON CATH 20MM 5.5CM |
| 04046964331701 | PDC146 SPECIAL BALLOON CATH 10MM 8CM |
| 04046964331688 | PDC147 SPECIAL BALLOON CATH 8MM 8CM |
| 04046964331657 | PDC149 SPECIAL BALLOON CATH 12MM 3CM |
| 04046964331596 | PDC053 SPECIAL BALLOON CATH 10MM 4CM |
| 04046964331534 | PDC051 SPECIAL BALLOON CATH 8MM 4CM |
| 04046964331350 | PDC104 SPECIAL BALLOON CATH 20MM 8CM |
| 04046964331336 | PDC103 SPECIAL BALLOON CATH 6MM 8CM |
| 04046964331312 | PDC102 SPECIAL BALLOON CATH 6MM 5CM |
| 04046964331275 | PDC060 SPECIAL BALLOON CATH 20MM X 10CM |
Trademark Results [TYSHAK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TYSHAK 75281664 2153776 Live/Registered |
NuMED, INC. 1997-04-24 |
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