Identity
- Trade Name
- MC3 Crescent Jugular Dual Lumen Catheter FDA UDI
- Generic Name
- Mobile extracorporeal gas exchange system catheter kit FDA UDI
- Device Name
- Dual Lumen ECMO Cannula FDA UDI
- Model / Reference
- 70124 FDA UDI
- Description
- Dual Lumen ECMO Cannula FDA UDI
Identifiers
- Catalog Number
- 70124 FDA UDI
- Primary DI / UDI-DI
- 10854916006789 FDA UDI
- FDA Product Code
- PZS FDA UDI
- GMDN Term
- Mobile extracorporeal gas exchange system catheter kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4100 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 24 French FDA UDI
Category: Mobile extracorporeal gas exchange system catheter kit
MC3 Crescent Jugular Dual Lumen Catheter by Michigan Critical Care Consultants, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mobile extracorporeal gas exchange system catheter kit.
- PROTEK DUO+ — SORIN GROUP ITALIA SRL · Class II
- PROTEK DUO+ — SORIN GROUP ITALIA SRL · Class II
- PROTEK DUO+ — SORIN GROUP ITALIA SRL · Class II
- PROTEK DUO+ — SORIN GROUP ITALIA SRL · Class II
- MC3 Crescent RA Dual Lumen Catheter 15FR — MICHIGAN CRITICAL CARE CONSULTANTS, INC. · Class II
- MC3 Crescent Jugular Dual Lumen Catheter — MICHIGAN CRITICAL CARE CONSULTANTS, INC. · Class II
- MC3 Crescent RA Dual Lumen Catheter 13FR — MICHIGAN CRITICAL CARE CONSULTANTS, INC. · Class II
- MC3 Crescent(tm) Jugular Dual Lumen Catheter — MICHIGAN CRITICAL CARE CONSULTANTS, INC. · Class II
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
- Michigan Critical Care Consultants, Inc.
Sources (1)
- FDA UDI 04eb5dcc-05ac-43f8-8c4b-078b4b134aa4 35 fields · synced May 31, 2026