UDI device identifier

i-STAT PTplus Cartridge 03P89-50

UDI device identifier 00054749004782 · Abbott Point of Care Inc.

Key facts

Primary DI 00054749004782
Brand name i-STAT PTplus Cartridge
Version or model 03P89-50
Catalog number 03P89-50
Company Abbott Point of Care Inc.
DUNS number 116279183
Product code GJS
GMDN term Prothrombin time (PT) IVD, kit, clotting
Premarket submission K220282
Device class Class II
Single use Yes
Packaged sterile Yes
Implantable No
Publish date Jan 10, 2024
Version date Jan 18, 2024
Description For the determination of prothrombin time.

At a glance

  • None 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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