UDI device identifier

Harmony™ HARMONY-DCS

UDI device identifier 00763000341367 · MEDTRONIC, INC.

Key facts

Primary DI 00763000341367
Brand name Harmony™
Version or model HARMONY-DCS
Company MEDTRONIC, INC.
DUNS number 006261481
Product code NPV
GMDN term Pulmonary transcatheter heart valve bioprosthesis
Premarket submission P200046
Device class HDE (Class III)
Single use Yes
Packaged sterile Yes
Implantable Yes
Publish date Apr 22, 2021
Version date Apr 30, 2021
Description HARMONY" DELIVERY CATHETER SYSTEM

At a glance

  • 10–99 MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 10–99 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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