Identity
- Trade Name
- Michigan Critical Care Consultants, Inc. FDA UDI
- Generic Name
- Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return FDA UDI
- Device Name
- Soft Flow Aortic Catheter 6MM Angled w. Flange Vented FDA UDI
- Model / Reference
- 7080 FDA UDI
- Description
- Soft Flow Aortic Catheter 6MM Angled w. Flange Vented FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10854916006383 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 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
Category: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
Michigan Critical Care Consultants, Inc. by Michigan Critical Care Consultants, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return.
- DLP® — MEDTRONIC, INC. · Class II
- DLP® — MEDTRONIC, INC. · Class II
- AESCULAP — AESCULAP, INC. · Class I
- PureFlex Arterial Cannulae — SORIN GROUP ITALIA SRL · Class II
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc. · Class II
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc. · Class II
- DLP® — MEDTRONIC, INC. · Class II
- Arterial cardiopulmonary bypass cannula — LivaNova USA, 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 229270d3-230c-4465-9095-15b9728e69f3 34 fields · synced Jun 1, 2026