UDI device identifier

MARK 5 NUVO LITE 925/60UK

UDI device identifier 00038214001285 · NIDEK MEDICAL PRODUCTS, INC.

Key facts

Primary DI 00038214001285
Brand name MARK 5 NUVO LITE
Version or model 925/60UK
Catalog number 925/60UK
Company NIDEK MEDICAL PRODUCTS, INC.
DUNS number 161382940
Product code CAW
GMDN term Stationary oxygen concentrator
Premarket submission K123738
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Aug 23, 2016
Version date Jul 6, 2018
Description 230V/60HZ OCSI OXYGEN CONCENTRATOR - UK PLUG

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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