Identity
- Trade Name
- C3 WAVE SYSTEM 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
- Catalog Number
- MRC3S01US FDA UDI
- Primary DI / UDI-DI
- 00884908133400 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
C3 Wave System 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medical Components Inc
Sources (1)
- FDA UDI 8cf2c90f-f50b-4081-b946-12c6678a7bd1 36 fields · synced Jun 8, 2026