Identity
- Trade Name
- i-STAT G3+ Cartridge FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent FDA UDI
- Device Name
- For the whole blood quantitative determination of pH pCO2 PO2 HCO3 TCO2 BE sO2 FDA UDI
- Model / Reference
- 03P78-26 FDA UDI
- Description
- For the whole blood quantitative determination of pH pCO2 PO2 HCO3 TCO2 BE sO2 FDA UDI
Identifiers
- Catalog Number
- 03P78-26 FDA UDI
- Primary DI / UDI-DI
- 00054749005673 FDA UDI
- 510(k) Number
- K223857 FDA UDI
- FDA Product Code
- CHL FDA UDI
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent 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
Yes
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, reagent
i-STAT G3+ Cartridge by Abbott Point of Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent.
- RAPIDPoint® 405/500 Measurement Cartridge — Siemens Healthcare Diagnostics · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- RAPIDPoint® 400 Measurement Cartridge — Siemens Healthcare Diagnostics · Class II
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class II
- H4 Cartridge — Lifehealth · Class II
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- EPOC BGEM CREA TEST CARD — Epocal Inc · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Point of Care Inc.
Sources (1)
- FDA UDI b09a94b8-e1af-4b7b-a949-0869adcde4a7 37 fields · synced Jun 9, 2026