FDA UDI
In Commercial Distribution
🇺🇸 United States
Ensemble™ ll
DI: 00643169713895
·
Model: ENS1020
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ensemble™ ll
- Primary DI
- 00643169713895
- Version / Model
- ENS1020
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-31
- Public Version
- 4
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 2e4d6b62-1de1-43bd-bd0d-77632a320dc6
Device Description
DELIV SYS ENS1020 ENSEMBLE II US
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NPV | Pulmonary valve prosthesis percutaneously delivered | Unknown | f |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60247 | Pulmonary transcatheter heart valve bioprosthesis | An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant pulmonary heart valve prosthesis (previously implanted), or native pulmonary valve anatomy that may have been surgically repaired, and which is designed to be implanted with a catheter via vascular access. It may be attached to an expandable metal framework which may be expanded with a balloon or self-expand, and may include other material types (e.g., synthetic polymer). Devices associated with implantation (e.g., catheter, introducer) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169713895 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P140017 | 004 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Outer Balloon Size 20 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight