FDA UDI
In Commercial Distribution
🇺🇸 United States
Epic™
DI: 05415067045447
·
Model: EMAX-21
·
ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epic™
- Primary DI
- 05415067045447
- Version / Model
- EMAX-21
- Catalog Number
- EMAX-21
- Company Name
- ST. JUDE MEDICAL, INC.
- Labeler DUNS
- 149818952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-01
- Public Version
- 1
- Public Version Date
- 2023-08-09
- Public Version Status
- New
- Public Device Record Key
- 5e3782d5-5fed-4efd-afab-0ffa5e05536d
Device Description
Max Stented Tissue Valve
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 |
|---|---|---|---|---|
| LWR | heart-valve, non-allograft tissue | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60242 | Aortic heart valve bioprosthesis | A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415067045447 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 16.0000 | Millimeter | |
| Lumen/Inner Diameter | 22.6000 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 41 – 77 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 77 Degrees Fahrenheit