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Edwards Lifesciences Aortic Perfusion Cannula

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
Edwards Lifesciences Aortic Perfusion Cannula FDA UDI
Generic Name
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return FDA UDI
Device Name
Aortic Perfusion Cannula FDA UDI
Model / Reference
PAA016CB FDA UDI
Description
Aortic Perfusion Cannula FDA UDI

Identifiers

Catalog Number
PAA016CB FDA UDI
Primary DI / UDI-DI
00690103033106 FDA UDI
510(k) Number
K123370 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
Not 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

Edwards Lifesciences Aortic Perfusion Cannula by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K123370 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edwards Lifesciences LLC

Sources (1)

  • FDA UDI 99927177-1422-4f7e-af4f-45f0e7c44f19 38 fields · synced Jun 8, 2026