FemoStop™ C11165
GUDID 15414734050033
Femoral Compression System
ST. JUDE MEDICAL, INC.
Femoral artery compression system, single-use| Primary Device ID | 15414734050033 |
| NIH Device Record Key | c89b5a13-26b5-4d36-b55e-a55468bc37f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FemoStop™ |
| Version Model Number | Gold |
| Catalog Number | C11165 |
| 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 | true |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734050036 [Primary] |
| GS1 | 15414734050033 [Package] Contains: 05414734050036 Package: [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110193
FDA Product Code
| DXC | CLAMP, VASCULAR |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-04-19 |
Devices Manufactured by ST. JUDE MEDICAL, INC.
| 05415067046734 - Ampere™ | 2025-01-22 Generator |
| 05415067046741 - Ampere™ | 2025-01-22 Generator Kit |
| 05415067046789 - Ampere™ | 2025-01-22 Remote Control |
| 05415067042934 - Regent™ | 2025-01-20 Mechanical Heart Valve |
| 05415067042958 - Regent™ | 2025-01-20 Mechanical Heart Valve |
| 05415067042972 - Masters Series™ | 2025-01-20 HP Mechanical Heart Valve |
| 05415067043016 - Masters Series™ | 2025-01-20 Mechanical Heart Valve |
| 05415067043030 - Masters Series™ | 2025-01-20 Mechanical Heart Valve |
Trademark Results [FemoStop]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FEMOSTOP 74460108 1898768 Live/Registered |
ST. JUDE MEDICAL COORDINATION CENTER BVBA 1993-11-18 |
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