ViewFlex™ Eco D087031-R
GUDID 05415067041630
Reprocessed ICE Catheter
ST. JUDE MEDICAL, INC.
Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed 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.
| 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 [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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