On-X Ascending Aortic Prosthesis ONXAAP-21

GUDID 00851788001518

Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position

ON-X LIFE TECHNOLOGIES, INC.

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

• Primary Device ID: 00851788001518
• NIH Device Record Key: ed153230-5a4b-4f5d-ba76-eae69ba95ea8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: On-X Ascending Aortic Prosthesis
• Version Model Number: ONXAAP-21
• Catalog Number: ONXAAP-21
• Company DUNS: 844782318
• Company Name: ON-X LIFE TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com
• Phone: 512-339-8000
• Email: onx@onxlti.com

Device Dimensions

• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage environment should be clean, cool, and dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage environment should be clean, cool, and dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage environment should be clean, cool, and dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage environment should be clean, cool, and dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage environment should be clean, cool, and dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage environment should be clean, cool, and dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage environment should be clean, cool, and dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage environment should be clean, cool, and dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage environment should be clean, cool, and dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851788001518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000037

FDA Product Code

• LWQ: Heart-Valve, Mechanical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-17
• Device Publish Date: 2014-09-12

On-Brand Devices [On-X Ascending Aortic Prosthesis]

• 00851788001549: Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic posit
• 00851788001532: Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic posit
• 00851788001525: Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic posit
• 00851788001518: Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic posit
• 00851788001501: Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic posit