UDI device identifier
Impella 0046-0035
UDI device identifier 00813502011869 · Abiomed, Inc.
Key facts
| Primary DI | 00813502011869 |
|---|---|
| Brand name | Impella |
| Version or model | 0046-0035 |
| Catalog number | 0046-0035 |
| Company | Abiomed, Inc. |
| DUNS number | 050636737 |
| Product code | PYX |
| GMDN term | Intracardiac circulatory assist axial-pump catheter |
| Premarket submission | P170011 |
| Device class | Class III |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Jun 19, 2023 |
| Version date | Jun 27, 2023 |
| Description | RP w Smart Assist Set, US |
At a glance
- 10–99 MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 1–9 GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: