FDA UDI
In Commercial Distribution
🇺🇸 United States
Masters Series™
DI: 05415067043696
·
Model: 33CAVGJ-514 00
·
ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Masters Series™
- Primary DI
- 05415067043696
- Version / Model
- 33CAVGJ-514 00
- Catalog Number
- 33CAVGJ-514 00
- Company Name
- ST. JUDE MEDICAL, INC.
- Labeler DUNS
- 149818952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-18
- Public Version
- 1
- Public Version Date
- 2024-12-26
- Public Version Status
- New
- Public Device Record Key
- c0b5f67e-a87f-4410-afa0-8bbd2091a8b9
Device Description
Aortic Valved Graft with Hemashield Graft technology Mechanical Valved Graft
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 | 05415067043696 | GS1 | ||||
| Previous | 05414734006644 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 33.0000 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 77 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 41 – 77 Degrees Fahrenheit