FDA UDI
In Commercial Distribution
🇺🇸 United States
On-X Ascending Aortic Prosthesis
DI: 00851788001501
·
Model: ONXAAP-19
·
ON-X LIFE TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- On-X Ascending Aortic Prosthesis
- Primary DI
- 00851788001501
- Version / Model
- ONXAAP-19
- Catalog Number
- ONXAAP-19
- Company Name
- ON-X LIFE TECHNOLOGIES, INC.
- Labeler DUNS
- 844782318
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-12
- Public Version
- 6
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 55d91e92-45bf-4f73-b7a1-3f1728af29dd
Device Description
Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWQ | Heart-Valve, Mechanical | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851788001501 | GS1 |
Customer Contacts
- Phone
- 512-339-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P000037 | 018 |
| P000037 | 019 |
| P000037 | 020 |
| P000037 | 021 |
| P000037 | 022 |
| P000037 | 023 |
| P000037 | 024 |
| P000037 | 026 |
| P000037 | 029 |
| P000037 | 031 |
| 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 Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 19 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage environment should be clean, cool, and dry
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 35 Degrees Celsius