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On-X Ascending Aortic Prosthesis

FDA UDIEUDAMED

Class III (US FDA UDI)

Ref ONXAAP-23

by On-X Life Technologies, Inc.

Identity

Trade Name
On-X® Ascending Aortic Prosthesis EUDAMED
On-X Ascending Aortic Prosthesis FDA UDI
Generic Name
Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft FDA UDI
Device Name
On-X® Ascending Aortic Prosthesis EUDAMED
Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position FDA UDI
Model / Reference
ONXAAP-23 EUDAMEDFDA UDI
Description
Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position FDA UDI

Identifiers

Catalog Number
ONXAAP-23 FDA UDI
Primary DI / UDI-DI
00851788001525 EUDAMEDFDA UDI
Basic UDI-DI
B-00851788001525 EUDAMED
PMA Number
P000037 FDA UDI
FDA Product Code
LWQ FDA UDI
EMDN Code
P07030299 MECHANICAL HEART VALVES - OTHER EUDAMED
GMDN Term
Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft FDA UDI

Classification

Device Class
Class III EUDAMEDFDA UDI
Market of Registration
Hungary EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 23 Millimeter FDA UDI

Category: Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft

On-X Ascending Aortic Prosthesis by On-X Life Technologies, Inc. — Class III — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft.

Cleared under the same submission

P000037 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
On-X Life Technologies, Inc.

Sources (2)

  • FDA UDI 87620f44-c7de-4140-b931-905de2e022b0 38 fields · synced Jun 11, 2026
  • EUDAMED 564f163c-04f5-4c43-8feb-f3221b300780 61 fields · synced Jun 11, 2026