UDI device identifier

Impella 0052-0011

UDI device identifier 00813502010015 · Abiomed, Inc.

Key facts

Primary DI 00813502010015
Brand name Impella
Version or model 0052-0011
Catalog number 0052-0011
Company Abiomed, Inc.
DUNS number 050636737
Product code DYB
GMDN term Vascular catheter introduction set, nonimplantable
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Oct 21, 2016
Version date Sep 9, 2025
Description Axillary Insertion Kit, PKGD

At a glance

  • None MAUDE reports citing this UDI
  • No 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:

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