Identity
- Trade Name
- On-X Ascending Aortic Prosthesis FDA UDI
- Generic Name
- Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft FDA UDI
- Device Name
- Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position FDA UDI
- Model / Reference
- ONXAAP-19 FDA UDI
- Description
- Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position FDA UDI
Identifiers
- Catalog Number
- ONXAAP-19 FDA UDI
- Primary DI / UDI-DI
- 00851788001501 FDA UDI
- PMA Number
- P000037 FDA UDI
- FDA Product Code
- LWQ FDA UDI
- GMDN Term
- Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
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 — 19 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 — FDA UDI — listed in FDA GUDID — 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 (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 III | Pending data |
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Manufacturer
- Manufacturer
- On-X Life Technologies, Inc.
Sources (1)
- FDA UDI 55d91e92-45bf-4f73-b7a1-3f1728af29dd 38 fields · synced May 30, 2026