FDA UDI
In Commercial Distribution
🇺🇸 United States
CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS - MITRAL
DI: 00690103021882
·
Model: 6625-ESR-LP
·
Edwards Lifesciences LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS - MITRAL
- Primary DI
- 00690103021882
- Version / Model
- 6625-ESR-LP
- Catalog Number
- 6625ESRLP27
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-08-30
- Public Version
- 4
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- a7846578-ec9d-4ae4-9db6-4ddc67936e4b
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| DYE | replacement Heart-valve | Cardiovascular | 870.3925 | 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 | 00690103021882 | GS1 |
Customer Contacts
- Phone
- +1(800)822-9837
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P870077 | 001 |
| P870077 | 002 |
| P870077 | 003 |
| P870077 | 013 |
| P870077 | 020 |
| P870077 | 027 |
| P870077 | 051 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | MOUNTING DIAMETER (ANNULUS), 27 MILLIMETER |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius