Fast-Cath™ 406844
GUDID 05414734202930
ST. JUDE MEDICAL, INC.
Vascular catheter introduction set, nonimplantable| Primary Device ID | 05414734202930 |
| NIH Device Record Key | d92cb95a-80fc-42fb-8c39-1ca63474e601 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fast-Cath™ |
| Version Model Number | SR0™ |
| Catalog Number | 406844 |
| 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 | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
| Catheter Gauge | 8 French |
| Length | 63 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734202930 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061015
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 | 2019-06-07 |
| Device Publish Date | 2015-04-11 |
On-Brand Devices [Fast-Cath™]
| 15415067009507 | 406750 |
| 15415067004786 | 406788 |
| 15415067000764 | 406350 |
| 15415067000757 | 406366 |
| 15415067000092 | 406749 |
| 05414734217293 | 406975 |
| 15414734217030 | 406724 |
| 15414734217023 | 406709 |
| 15414734217016 | 406708 |
| 15414734217009 | 406707 |
| 15414734216996 | 406706 |
| 15414734216989 | 406705 |
| 15414734216972 | 406704 |
| 15414734216965 | 406703 |
| 15414734216958 | 406702 |
| 15414734216941 | 406701 |
| 15414734216934 | 406700 |
| 15414734216910 | 406543 |
| 05414734204057 | Trio |
| 15414734204047 | Trio |
| 05414734204026 | Trio |
| 05414734203999 | Trio |
| 15414734203965 | Trio |
| 15414734203941 | Trio |
| 15414734203927 | Trio |
| 15414734203903 | Trio |
| 15414734203873 | Duo |
| 15414734203859 | Duo |
| 15414734203835 | Duo |
| 15414734203811 | Duo |
| 05414734203654 | 407438 |
| 05414734203647 | 407436 |
| 05414734203616 | SL2™ |
| 05414734203609 | SL1™ |
| 05414734203579 | SL1™ |
| 05414734203562 | SL0™ |
| 05414734203548 | SL0™ |
| 05414734203531 | SL0™ |
| 05414734203456 | 406902 |
| 05414734203449 | 406901 |
| 05414734203418 | SL4™ |
| 05414734203401 | SL3™ |
| 05414734203395 | SL2™ |
| 05414734203388 | SL1™ |
| 05414734203371 | SL4™ |
| 05414734203364 | SL3™ |
| 05414734203357 | SL2™ |
| 05414734203340 | SL1™ |
| 05414734203319 | 406805 |
| 05414734203302 | 406804 |
Trademark Results [Fast-Cath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FAST-CATH 74418555 1901190 Live/Registered |
KPR U.S., LLC 1993-07-19 |
 FAST-CATH 74047908 not registered Dead/Abandoned |
Daig Corporation 1990-04-11 |
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