Identity
- Trade Name
- i-STAT FDA UDI
- Generic Name
- Potassium (K+) electrode IVD FDA UDI
- Device Name
- EC8+ CARTRIDGE FDA UDI
- Model / Reference
- 03P79-25 FDA UDI
- Description
- EC8+ CARTRIDGE FDA UDI
Identifiers
- Catalog Number
- 03P79-25 FDA UDI
- Primary DI / UDI-DI
- 10054749000071 FDA UDI
- 510(k) Number
- K940918 FDA UDI
- FDA Product Code
- CHL FDA UDI
- GMDN Term
- Potassium (K+) electrode IVD 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: Urea IVD, reagentMultiple blood gas/haemoximetry/electrolyte analyte IVD, reagentBlood gas/haemoximetry analyser IVD, point-of-careSodium (Na+) electrode IVD
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 Potassium (K+) electrode IVD.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class II
- Potassium Electrode — Medica Corp. · Class II
- Ready Sensor™ GOLD Potassium Sensor — Siemens Healthcare Diagnostics · Class II
- Alfa Wassermann — Alfa Wassermann, Inc. · Class II
- RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor — Siemens Healthcare Diagnostics · Class II
- ISE Potassium Electrode — STANBIO LABORATORY, L.P. · Class II
- I.S.E. K — Randox Laboratories, Ltd. · Class II
- ISE Potassium Electrode — Medica Corp. · Class II
Cleared under the same submission
K940918 also covers:
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 |
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Manufacturer
- Manufacturer
- Abbott Point of Care Inc.
Sources (1)
- FDA UDI 7a1e9ca1-1bd0-41f5-ad93-b54f0e4b5960 37 fields · synced Jun 9, 2026