Identity
- Trade Name
- C3 WAVEC3 WAVE FDA UDI
- Generic Name
- Central venous catheter navigation system, electrocardiographic FDA UDI
- Device Name
- C3 WAVE NAVIGATION SYSTEM W/IPAD® FDA UDI
- Model / Reference
- MRC3S01US FDA UDI
- Description
- C3 WAVE NAVIGATION SYSTEM W/IPAD® FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884908129366 FDA UDI
- FDA Product Code
- LJS FDA UDI
- GMDN Term
- Central venous catheter navigation system, electrocardiographic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5970 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
C3 Wavec3 Wave by Medical Components 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
- Medical Components Inc
Sources (1)
- FDA UDI c305bd33-142f-434b-957b-5fe77033d692 35 fields · synced May 31, 2026