Identity
- Trade Name
- OmniWire Pressure Guide Wire EUDAMEDFDA UDI
- Generic Name
- Catheter-tip transducer, pressure FDA UDI
- Device Name
- OmniWire EUDAMED
- Model / Reference
- 89185J EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 89185J FDA UDI
- Primary DI / UDI-DI
- 00845225003050 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00845225003050 EUDAMED
- FDA Product Code
- DQX FDA UDIDXO FDA UDI
- EMDN Code
- C04010101 CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC EUDAMED
- GMDN Term
- Catheter-tip transducer, pressure FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1330 FDA UDI870.2870 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — .014 Inch FDA UDILength — 185 Centimeter FDA UDI
OmniWire Pressure Guide Wire by Volcano Corporation — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00845225003050 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Volcano Corporation
- EUDAMED SRN
- US-MF-000020094
- Authorised Representative
- Volcano Europe BE-AR-000000929
Sources (2)
- EUDAMED 669307fb-8499-4c79-a0b8-fbf68c362fe8 61 fields · synced Jun 8, 2026
- FDA UDI 6221f614-fa25-45da-b750-cf8222ed1706 37 fields · synced May 25, 2026