FemoStop™ C11165
GUDID 15414734050033
Femoral Compression System
ST. JUDE MEDICAL, INC.
Femoral artery compression system, single-use Femoral artery compression system dome Femoral artery compression system dome Femoral artery compression system dome Femoral artery compression system dome Femoral artery compression system dome Femoral artery compression system dome Femoral artery compression system dome Femoral artery compression system dome Femoral artery compression system dome Femoral artery compression system dome Femoral artery compression system dome Femoral artery compression system dome Femoral artery compression system dome Femoral artery compression system dome Femoral artery compression system dome Femoral artery compression system dome Femoral artery compression system dome| 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.
| 05415067047700 - TriClip™ | 2024-04-22 G4 Delivery System |
| 05415067047724 - TriClip™ | 2024-04-22 G4 Delivery System |
| 05415067047731 - TriClip™ | 2024-04-22 G4 Delivery System |
| 05415067047748 - TriClip™ | 2024-04-22 Steerable Guide Catheter |
| 05415067047755 - TriClip™ | 2024-04-22 G4 Delivery System |
| 05415067050014 - EnSite™ | 2024-04-04 X EP System Software Upgrade |
| 05415067050021 - EnSite™ | 2024-04-04 X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade |
| 05415067050281 - EnSite™ | 2024-04-04 X EP System PFA Catheter Visualization Temporary Software License |
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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