i-STAT 03P83-25

• EUDAMED Basic UDI-DI B-00054749000111 registered 1 Sep 2026 Active
• FDA 510(k) K894914 decided 16 Oct 1989 Active
• FDA GUDID UDI-DI 00054749000111 listed 9 Sep 2016 Listed

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

• • Terminated Z-1540-2009 FDA Unclassified (pre-2012) ·initiated 23 Feb 2009 ·on shared 510(k) K894914

  Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.

• 4 recalls, same reason

  • Terminated Z-0372-2008 FDA Unclassified (pre-2012) ·initiated 18 Oct 2007
  • Terminated Z-0375-2008 FDA Unclassified (pre-2012) ·initiated 18 Oct 2007
  • Terminated Z-0371-2008 FDA Unclassified (pre-2012) ·initiated 18 Oct 2007
  • Terminated Z-0374-2008 FDA Unclassified (pre-2012) ·initiated 18 Oct 2007

  Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

• • Terminated Z-1171-06 FDA Unclassified (pre-2012) ·initiated 24 May 2006

  Erroneous sodium and/or ionized calcium readings with a patient sample could be obtained

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 16 Oct 1989 Cleared FDA 510(k) K894914
2. 24 May 2006 Recall initiated FDA recalls Z-1171-06
3. 18 Oct 2007 Recall initiated FDA recalls Z-0372-2008
4. 18 Oct 2007 Recall initiated FDA recalls Z-0375-2008
5. 18 Oct 2007 Recall initiated FDA recalls Z-0371-2008
6. 18 Oct 2007 Recall initiated FDA recalls Z-0374-2008
7. 23 Feb 2009 Recall initiated FDA recalls Z-1540-2009
8. 9 Sep 2016 Listed FDA GUDID 00054749000111
9. 1 Sep 2026 Registered EUDAMED B-00054749000111

Trade name

i-STAT

Generic name

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Device name

i-STAT G Cartridge

Model / Ref / Catalog

03P83-25

Primary DI / UDI-DI

00054749000111 EUDAMED

10054749000118 GUDID

Basic UDI-DI

B-00054749000111

510(k) Number

K894914 ↗

FDA product code

JGS

EMDN code

W0101070202 Glucose - electrodes

GMDN term

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Device class

Class IVD General EUDAMED

Class II GUDID

Regulation number

862.1665

EU registration type

Legacy device (under a directive)

EU market of registration

Germany

GUDID distribution status

In Commercial Distribution

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00054749000111; FDA GUDID lists 10054749000118), so their flags are not compared. Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

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