FDA UDI
In Commercial Distribution
🇺🇸 United States
MITRIS RESILIA Mitral Valve
DI: 00690103205565
·
Model: 11400M
·
Edwards Lifesciences LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MITRIS RESILIA Mitral Valve
- Primary DI
- 00690103205565
- Version / Model
- 11400M
- Catalog Number
- 11400M31
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-23
- Public Version
- 1
- Public Version Date
- 2022-03-31
- Public Version Status
- New
- Public Device Record Key
- 3624688a-88c6-4798-810d-9d1ea2360f35
Device Description
RESILIA Mitral Valve, size 31 mm
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
- Yes
- 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 |
|---|---|---|---|---|
| 60244 | Mitral 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 mitral 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 | 00690103205565 | GS1 |
Customer Contacts
- Phone
- +1(800)822-9837
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150048 | 047 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 31MM |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place.