AccessGUDID - DEVICE: On-X Ascending Aortic Prosthesis (00851788001532)

GUDID

Device Identifier (DI) Information

Brand Name: On-X Ascending Aortic Prosthesis
Version or Model: ONXAAP-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ONXAAP-25
Company Name: ON-X LIFE TECHNOLOGIES, INC.

Primary DI Number: 00851788001532
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 844782318 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60423	Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft	An artificial substitute for a natural aortic heart valve fitted with a length of biologic-polymer blood vessel (vascular graft) intended to be implanted during open heart surgery to simultaneously replace a dysfunctional aortic heart valve and repair/replace a damaged or diseased ascending aorta (e.g., in cases of aneurysm, dissection or dilatation). The valve component consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that pivot about struts attached to the valve housing by hinges; the synthetic polymer blood vessel is designed to conform to the aortic root anatomy and is impregnated with a bioabsorbable animal-derived gelatin.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LWQ	Heart-Valve, Mechanical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000037	018
P000037	019
P000037	020
P000037	021
P000037	022
P000037	023
P000037	024
P000037	025
P000037	026
P000037	029
P000037	032
P000037	035
P000037	036
P000037	038
P000037	039
P000037	043
P000037	045
P000037	046
P000037	047
P000037	050
P000037	051
P000037	052
P000037	053

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Storage environment should be clean, cool, and dry
Storage Environment Temperature: between 0 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 25 Millimeter

Device Record Status

Public Device Record Key: d4810044-d00a-4793-b7ea-13e5bb60eb6d
Public Version Date: February 05, 2021
Public Version Number: 6
DI Record Publish Date: September 12, 2014