TYSHAK Mini® 611985
GUDID 04046964339639
PDC400 TYSHAK MINI 4MM 2CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
Cardiac valvuloplasty catheter| Primary Device ID | 04046964339639 |
| NIH Device Record Key | 05928407-a8a7-4bbc-ae58-2de793712061 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TYSHAK Mini® |
| Version Model Number | 611985 |
| Catalog Number | 611985 |
| 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 *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 | 04046964339639 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K003276
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 Mini®]
| 04046964339981 | SO101 TYSHAK MINI 7MM, 1CM, 3F |
| 04046964339950 | SO104 TYSHAK MINI 10MM, 1CM, 4F |
| 04046964339936 | SO103 TYSHAK MINI 9MM, 1CM, 4F |
| 04046964339912 | SO102 TYSHAK MINI 8MM, 1CM, 3F |
| 04046964339851 | SO098 TYSHAK MINI 6MM, 1CM, 3 FR |
| 04046964339837 | SO097 TYSHAK MINI 5MM, 1CM, 3FR |
| 04046964339813 | SO095 TYSHAK MINI 4MM, 1 CM, 3 FR |
| 04046964339790 | PDC408 TYSHAK MINI 10MM 4CM |
| 04046964339776 | PDC407 TYSHAK MINI 9MM 4CM |
| 04046964339752 | PDC406 TYSHAK MINI 10MM 2CM |
| 04046964339738 | PDC405 TYSHAK MINI 9MM 2CM |
| 04046964339714 | PDC404 TYSHAK MINI 8MM 2CM |
| 04046964339691 | PDC403 TYSHAK MINI 7MM 2CM |
| 04046964339677 | PDC402 TYSHAK MINI 6MM 2CM |
| 04046964339653 | PDC401 TYSHAK MINI 5MM 2CM |
| 04046964339639 | PDC400 TYSHAK MINI 4MM 2CM |
Trademark Results [TYSHAK Mini]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TYSHAK MINI 76014840 2521207 Live/Registered |
NUMED, INC. 2000-03-31 |
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