Amulet™ STRBL-14F-075
GUDID 05415067049094
Steerable Delivery Sheath
ST. JUDE MEDICAL, INC.
Cardiac occluder delivery kit| Primary Device ID | 05415067049094 |
| NIH Device Record Key | 6281d7d8-e7b1-4a43-954a-60113b96baed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Amulet™ |
| Version Model Number | STRBL-14F-075 |
| Catalog Number | STRBL-14F-075 |
| 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 | false |
| 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 |
Device Dimensions
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
| Catheter Gauge | 14 French |
| Length | 75 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067049094 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K232690
FDA Product Code
| DQY | Catheter, percutaneous |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-10 |
| Device Publish Date | 2023-10-02 |
Devices Manufactured by ST. JUDE MEDICAL, INC.
| 05415067055507 - Zenex MRI™ | 2026-01-30 SR Pacemaker |
| 05415067055514 - Zenex MRI™ | 2026-01-30 DR Pacemaker |
| 05415067036650 - Navitor™ | 2026-01-26 Loading System |
| 05415067036667 - Navitor™ | 2026-01-26 Loading System |
| 05415067055613 - EnSite™ | 2026-01-16 X EP System Software Upgrade |
| 05415067051417 - Current™ | 2026-01-14 PFA Radiolucent ECG Lead Set |
| 05415067051516 - Current™ | 2026-01-14 PFA Generator |
| 05415067051554 - Current™ | 2026-01-14 PFA ECG Trunk Cable |
Trademark Results [Amulet]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMULET 98876212 not registered Live/Pending |
Teddybot, Inc. 2024-11-27 |
 AMULET 98542830 not registered Live/Pending |
New Ravenna, LLC 2024-05-09 |
 AMULET 98533262 not registered Live/Pending |
STAT Health Informatics, Inc. 2024-05-03 |
 AMULET 98133140 not registered Live/Pending |
Purina Animal Nutrition LLC 2023-08-15 |
 AMULET 98124974 not registered Live/Pending |
St. Jude Medical, Cardiology Division, Inc. 2023-08-09 |
 AMULET 97236581 not registered Live/Pending |
Allergy Amulet, Inc. 2022-01-25 |
 AMULET 90623733 not registered Live/Pending |
AMULET ESTATE LLC 2021-04-05 |
 AMULET 88337414 not registered Live/Pending |
SHENZHEN UWELL TECHNOLOGY CO., LTD. 2019-03-13 |
 AMULET 88319376 5850824 Live/Registered |
Shandong Jinyu Rubber Technology Co., Ltd. 2019-02-28 |
 AMULET 87536378 not registered Dead/Abandoned |
Bose Corporation 2017-07-20 |
 AMULET 87303074 not registered Dead/Abandoned |
Ballistic Furniture Systems, Inc. 2017-01-16 |
 AMULET 87138181 5267544 Live/Registered |
St. Jude Medical, Cardiology Division, Inc. 2016-08-15 |
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