Swartz™ 407453
GUDID 05414734205771
ST. JUDE MEDICAL, INC.
Cardiac transseptal access set| Primary Device ID | 05414734205771 |
| NIH Device Record Key | 35d4baef-892b-42e1-94b9-231f10d97a6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Swartz™ |
| Version Model Number | SL1™ |
| Catalog Number | 407453 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, 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 | true |
| 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
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| Catheter Gauge | 8.5 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734205771 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052644
FDA Product Code
| DYB | INTRODUCER, CATHETER |
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 | 2019-01-23 |
| Device Publish Date | 2015-04-09 |
On-Brand Devices [Swartz™]
| 05414734205832 | SL4™ |
| 05414734205818 | SL3™ |
| 05414734205801 | SL2™ |
| 05414734205795 | SL2™ |
| 05414734205788 | SL1™ |
| 05414734205771 | SL1™ |
| 05414734205764 | SL0™ |
| 05414734205757 | SL0™ |
| 05414734205740 | SL0™ |
| 05414734205733 | SL0™ |
| 05414734205702 | SL4™ |
| 05414734205672 | SL3™ |
| 05414734205658 | SL2™ |
| 05414734205641 | SL1™ |
| 05414734205634 | SL1™ |
| 05414734205627 | LAMP™ 135º |
| 05414734205610 | LAMP™ 135º |
| 05414734205597 | LAMP 135º |
| 05414734205580 | LAMP™ 45º |
| 05414734205573 | LAMP™ 45º |
| 05414734205559 | LAMP™ 45º |
| 05414734205542 | LAMP™ 90º |
| 05414734205535 | LAMP™ 90º |
| 05414734205511 | LAMP™ 90º |
Trademark Results [Swartz]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SWARTZ 77629434 3711321 Dead/Cancelled |
Swartz, Elizabeth Ann 2008-12-09 |
 SWARTZ 76324069 2658865 Live/Registered |
SMC ELECTRICAL PRODUCTS, INC. 2001-10-12 |
 SWARTZ 74657900 1996285 Dead/Cancelled |
SMC ELECTRICAL PRODUCTS, INC. 1995-04-10 |
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