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Arterial cardiopulmonary bypass cannula

FDA UDI

Class II (US FDA UDI)

by LivaNova USA, Inc.

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
00803622104329 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
MRI Safety
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.

Cleared under the same submission

K943934 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LivaNova USA, Inc.

Sources (1)

  • FDA UDI 77f9c3f8-9d64-416f-970d-533aee703b3a 33 fields · synced Jun 8, 2026