Identity
- Trade Name
- ViewFlex™ Eco FDA UDI
- Generic Name
- Intracardiac ultrasound imaging catheter, steerable, reprocessed FDA UDI
- Device Name
- Reprocessed ICE Catheter FDA UDI
- Model / Reference
- D087031-R FDA UDI
- Description
- Reprocessed ICE Catheter FDA UDI
Identifiers
- Catalog Number
- D087031-R FDA UDI
- Primary DI / UDI-DI
- 05415067041630 FDA UDI
- FDA Product Code
- OWQ FDA UDI
- GMDN Term
- Intracardiac ultrasound imaging catheter, steerable, reprocessed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 90.0000 Centimeter FDA UDICatheter Gauge — 9.0000 French FDA UDI
Category: Intracardiac ultrasound imaging catheter, steerable, reprocessed
ViewFlex™ Eco by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI a69f4ad0-19c0-4e4f-bdba-57577837ab31 37 fields · synced May 30, 2026