Identity
- Trade Name
- Arterial cardiopulmonary bypass cannula FDA UDI
- Generic Name
- Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return FDA UDI
- Model / Reference
- NA-xxxxx FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00803622104411 FDA UDI00803622104381 FDA UDI00803622104152 FDA UDI00803622106651 FDA UDI
- 510(k) Number
- K943934 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
MR Unsafe FDA UDI
Category: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
Arterial cardiopulmonary bypass cannula by LivaNova USA, 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
- DLP® — MEDTRONIC, INC. · Class II
- PureFlex Arterial Cannulae — SORIN GROUP ITALIA SRL · Class II
- DLP® — MEDTRONIC, INC. · Class II
- Paediatric Arterial Cannula — SORIN GROUP ITALIA SRL · Class II
Cleared under the same submission
K943934 also covers:
- Aortic Arch Cannula — LivaNova USA, Inc.
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc.
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc.
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc.
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc.
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc.
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc.
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc.
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc.
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc.
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc.
- Arterial cardiopulmonary bypass cannula — LivaNova USA, Inc.
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
- LivaNova USA, Inc.
Sources (4)
- FDA UDI 7e4da0e8-bf47-4ce4-8441-4f9af38a8992 33 fields · synced Jun 8, 2026
- FDA UDI 47f0e97a-5bd7-4665-885a-e0f7f4c6deb6 33 fields · synced May 26, 2026
- FDA UDI 6065c488-f0dc-4990-a325-f34c5c5f0a23 33 fields · synced May 26, 2026
- FDA UDI bc3553f4-0407-4bfd-b584-40a65f6b3b71 33 fields · synced May 27, 2026