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On-X Ascending Aortic Prosthesis
FDA UDIEUDAMEDClass III (US FDA UDI)
Ref ONXAAP-27/29
Identity
- Trade Name
- On-X® Ascending Aortic Prosthesis EUDAMEDOn-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 EUDAMEDBileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position FDA UDI
- Model / Reference
- ONXAAP-27/29 EUDAMEDFDA UDI
- Description
- Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position FDA UDI
Identifiers
- Catalog Number
- ONXAAP-27/29 FDA UDI
- Primary DI / UDI-DI
- 00851788001549 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00851788001549 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 27 Millimeter FDA UDIOuter Diameter — 28 Millimeter FDA UDIOuter Diameter — 29 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
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Cleared under the same submission
P000037 also covers:
- On-X Aortic Heart Valve with Anatomic Sewing Ring — ON-X LIFE TECHNOLOGIES, INC.
- On-X Aortic Heart Valve with Anatomic Sewing Ring — ON-X LIFE TECHNOLOGIES, INC.
- On-X Aortic Heart Valve with Anatomic Sewing Ring — ON-X LIFE TECHNOLOGIES, INC.
- On-X Aortic Heart Valve with Anatomic Sewing Ring — ON-X LIFE TECHNOLOGIES, INC.
- On-X Aortic Heart Valve with Anatomic Sewing Ring — ON-X LIFE TECHNOLOGIES, INC.
- On-X Aortic Heart Valve with Anatomic Sewing Ring and Extended Holder — ON-X LIFE TECHNOLOGIES, INC.
- On-X Aortic Heart Valve with Anatomic Sewing Ring and Extended Holder — ON-X LIFE TECHNOLOGIES, INC.
- On-X Aortic Heart Valve with Anatomic Sewing Ring and Extended Holder — ON-X LIFE TECHNOLOGIES, INC.
- On-X Aortic Heart Valve with Conform-X Sewing Ring — ON-X LIFE TECHNOLOGIES, INC.
- On-X Aortic Heart Valve with Conform-X Sewing Ring — ON-X LIFE TECHNOLOGIES, INC.
- On-X Aortic Heart Valve with Conform-X Sewing Ring — ON-X LIFE TECHNOLOGIES, INC.
- On-X Aortic Heart Valve with Conform-X Sewing Ring — ON-X LIFE TECHNOLOGIES, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- On-X Life Technologies, Inc.
Sources (2)
- FDA UDI ba3b558b-c707-49ed-821c-21df17756f3c 38 fields · synced Jul 14, 2026
- EUDAMED 4506b059-c71d-44f4-b242-b269bf83e769 61 fields · synced Jul 14, 2026