UDI device identifier
Impella 1000434
UDI device identifier 00813502012996 · Abiomed, Inc.
Key facts
| Primary DI | 00813502012996 |
|---|---|
| Brand name | Impella |
| Version or model | 1000434 |
| Catalog number | 1000434 |
| Company | Abiomed, Inc. |
| DUNS number | 050636737 |
| Product code | DYB |
| GMDN term | Vascular catheter introduction set, nonimplantable |
| Premarket submission | K222113 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | May 31, 2023 |
| Version date | Mar 20, 2024 |
| Description | Kit, Low Profile, 14Fr, Short, 1UP |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 1,000+ 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: