ViewFlex™ Eco D087031-R
GUDID 05415067041630
Reprocessed ICE Catheter
ST. JUDE MEDICAL, INC.
Intracardiac ultrasound imaging catheter, steerable, reprocessed| Primary Device ID | 05415067041630 |
| NIH Device Record Key | a69f4ad0-19c0-4e4f-bdba-57577837ab31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ViewFlex™ Eco |
| Version Model Number | D087031-R |
| Catalog Number | D087031-R |
| 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 | false |
| Serial Number | true |
| 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 | |
| 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
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
| Length | 90 Centimeter |
| Catheter Gauge | 9 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067041630 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K222217
FDA Product Code
| OWQ | Reprocessed intravascular ultrasound 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 | 2 |
| Public Version Date | 2023-06-13 |
| Device Publish Date | 2023-01-18 |
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 [ViewFlex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIEWFLEX 98387123 not registered Live/Pending |
St. Jude Medical, Atrial Fibrillation Division, Inc. 2024-02-01 |
 VIEWFLEX 87383535 not registered Dead/Abandoned |
NURICON Co., Ltd. 2017-03-23 |
 VIEWFLEX 87285087 5269952 Live/Registered |
Shenzhen ViewFlex Intelligent Technology Co.,LTD 2016-12-30 |
 VIEWFLEX 77046923 3285055 Live/Registered |
ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC. 2006-11-17 |
 VIEWFLEX 76386852 2822177 Dead/Cancelled |
DNP Denmark A/S 2002-03-22 |
 VIEWFLEX 75704072 not registered Dead/Abandoned |
ALTINEX, INC. 1999-05-13 |
 VIEWFLEX 73735204 1539057 Dead/Cancelled |
ESHED ROBOTEC (1982) LTD. 1988-06-20 |
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