FDA UDI
In Commercial Distribution
🇺🇸 United States
EXCOR® VAD
DI: 04260090041352
·
Model: C80G-021m
·
Berlin Heart GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EXCOR® VAD
- Primary DI
- 04260090041352
- Version / Model
- C80G-021m
- Company Name
- Berlin Heart GmbH
- Labeler DUNS
- 328654384
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-06
- Public Version
- 7
- Public Version Date
- 2023-06-26
- Public Version Status
- Update
- Public Device Record Key
- 180e6deb-3d87-458f-a035-1b36cd5ebfad
Device Description
Arterial cannula for small children
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
- No
- Has Lot/Batch Number
- Yes
- 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 | 04260090041352 | GS1 |
Customer Contacts
- Phone
- 1.281.863.9700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160035 | 001 |
| P160035 | 002 |
| P160035 | 004 |
| P160035 | 011 |
| P160035 | 016 |
| P160035 | 019 |
| P160035 | 024 |
| P160035 | 032 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 35 – 50 Percent (%) Relative Humidity