UDI device identifier

i-STAT 06P17-01

UDI device identifier 00054749001170 · ABBOTT POINT OF CARE INC.

Key facts

Primary DI 00054749001170
Brand name i-STAT
Version or model 06P17-01
Catalog number 06P17-01
Company ABBOTT POINT OF CARE INC.
DUNS number 079226216
Product code JJY
GMDN term Creatine kinase myocardial isoenzyme (CKMB) IVD, control
Device class Class I
Single use Yes
Packaged sterile No
Implantable No
Publish date Jun 23, 2023
Version date Jul 3, 2023
Description i-STAT CK-MB, Control Level 1

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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