FDA UDI
In Commercial Distribution
🇺🇸 United States
EXCOR® VAD
DI: 04260090040102
·
Model: P10P-001
·
Berlin Heart GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EXCOR® VAD
- Primary DI
- 04260090040102
- Version / Model
- P10P-001
- Company Name
- Berlin Heart GmbH
- Labeler DUNS
- 328654384
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 7
- Public Version Date
- 2023-06-30
- Public Version Status
- Update
- Public Device Record Key
- b5d06d68-d97d-4b1d-a806-7b534f45486d
Device Description
Blood pump PU valves; 10ml
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 Unsafe
- 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 |
|---|---|---|---|---|
| DSQ | Ventricular (Assisst) Bypass | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10847 | External ventricular circulatory assist system | An assembly of devices intended to assist a damaged or weakened heart (e.g., one affected by cardiogenic shock) to pump blood. It includes a mains electricity (AC-powered) external pump, an atrial or ventricular cannula to draw blood outside the body, a cannula to deliver the blood back to the aorta or pulmonary artery (depending on left or right ventricular assistance), and a unit that controls pump operation. It is typically intended to be used as a bridge to heart transplantation; it is not intended for cardiopulmonary bypass. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260090040102 | GS1 |
Customer Contacts
- Phone
- 1.281.863.9700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H100004 | 003 |
| H100004 | 004 |
| H100004 | 006 |
| H100004 | 008 |
| H100004 | 010 |
| H100004 | 012 |
| H100004 | 013 |
| H100004 | 014 |
| H100004 | 017 |
| H100004 | 020 |
| H100004 | 021 |
| P160035 | 000 |
| P160035 | 001 |
| P160035 | 003 |
| P160035 | 004 |
| P160035 | 007 |
| P160035 | 009 |
| P160035 | 010 |
| P160035 | 011 |
| P160035 | 013 |
| P160035 | 014 |
| P160035 | 016 |
| P160035 | 017 |
| P160035 | 019 |
| P160035 | 021 |
| P160035 | 023 |
| P160035 | 024 |
| P160035 | 027 |
| P160035 | 030 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 35 – 50 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius