Identity
- Trade Name
- pH Electrode FDA UDI
- Generic Name
- Blood gas pH IVD, kit, ion-selective electrode (ISE) FDA UDI
- Device Name
- pH electrode for use with EasyBloodGas and EasyStat analyzers FDA UDI
- Model / Reference
- 6201 FDA UDI
- Description
- pH electrode for use with EasyBloodGas and EasyStat analyzers FDA UDI
Identifiers
- Catalog Number
- 6201 FDA UDI
- Primary DI / UDI-DI
- 00386100002305 FDA UDI
- 510(k) Number
- K974526 FDA UDI
- FDA Product Code
- CHL FDA UDI
- GMDN Term
- Blood gas pH 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 pH IVD, kit, ion-selective electrode (ISE)
pH Electrode by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood gas pH IVD, kit, ion-selective electrode (ISE).
- Electrode for ABL analyzers — Radiometer Medical ApS · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA UDI 8849640f-efcb-4a08-bc7b-4a63b2d12d91 37 fields · synced May 31, 2026