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i-STAT

FDA UDI

Class II (US FDA UDI)

by Abbott Point of Care Inc.

Identity

Trade Name
i-STAT FDA UDI
Generic Name
Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI
Device Name
G3+ CARTRIDGE FDA UDI
Model / Reference
03P78-25 FDA UDI
Description
G3+ CARTRIDGE FDA UDI

Identifiers

Catalog Number
03P78-25 FDA UDI
Primary DI / UDI-DI
10054749000064 FDA UDI
510(k) Number
K940918 FDA UDI
FDA Product Code
CHL FDA UDI
GMDN Term
Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagentBlood gas/haemoximetry analyser IVD, point-of-care

i-STAT by Abbott Point of Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood gas/haemoximetry analyser IVD, point-of-care.

Cleared under the same submission

K940918 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Point of Care Inc.

Sources (1)

  • FDA UDI 1106bd6b-5268-4873-a25e-2944edb0444f 37 fields · synced Jun 9, 2026