Identity
- Trade Name
- pO2 Electrode FDA UDI
- Generic Name
- Blood gas pO2 IVD, kit, ion-selective electrode (ISE) FDA UDI
- Device Name
- pO2 electrode for use with EasyBloodGas and EasyStat Analyzers FDA UDI
- Model / Reference
- 6203 FDA UDI
- Description
- pO2 electrode for use with EasyBloodGas and EasyStat Analyzers FDA UDI
Identifiers
- Catalog Number
- 6203 FDA UDI
- Primary DI / UDI-DI
- 00386100002329 FDA UDI
- 510(k) Number
- K974526 FDA UDI
- FDA Product Code
- CHL FDA UDI
- GMDN Term
- Blood gas pO2 IVD, kit, ion-selective electrode (ISE) 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Category: Blood gas pO2 IVD, kit, ion-selective electrode (ISE)
pO2 Electrode by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Medica Corp.
Sources (1)
- FDA UDI f979cb89-c1de-4f78-8dd3-6c6c3ae6cc9e 37 fields · synced May 31, 2026