Identity
- Trade Name
- InQwire® EUDAMEDFDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- Diagnostic Guide Wires EUDAMED
- Model / Reference
- InQwire® EUDAMEDIQ35F150S/B EUDAMED00884450004890 FDA UDI
Identifiers
- Catalog Number
- IQ35F150S/B FDA UDI
- Primary DI / UDI-DI
- 00884450004890 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884450004890 EUDAMED
- FDA Product Code
- DQX FDA UDI
- EMDN Code
- C04020102 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC EUDAMED
- GMDN Term
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1330 FDA UDI
- Market of Registration
- Netherlands 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Category: Cardiac/peripheral vascular guidewire, single-use
InQwire® by Merit Medical Systems, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (2)
- FDA UDI 5ec63b6b-3d74-46be-b563-57286fced88b 34 fields · synced Oct 9, 2026
- EUDAMED 42107e1e-f7b3-4989-8d75-8fa501a9d7aa 61 fields · synced Oct 8, 2026