UDI device identifier

LEADER 5512934

UDI device identifier 00096295137385 · Cardinal Health 110, Inc.

Key facts

Primary DI 00096295137385
Brand name LEADER
Version or model 5512934
Catalog number 5512934
Company Cardinal Health 110, Inc.
DUNS number 063997360
Product code MSH
GMDN term Public respirator, single-use
Premarket submission K061375
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Feb 10, 2020
Version date Sep 13, 2023
Description LDR N95 Masks 5 ea

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 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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