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ISE Lithium Electrode

FDA UDI

Class II (US FDA UDI)

by Medica Corp.

Identity

Trade Name
ISE Lithium Electrode FDA UDI
Generic Name
Lithium electrode IVD FDA UDI
Device Name
ISE Lithium Electrode for use with EasyElectrolyte Analyzers FDA UDI
Model / Reference
5205 FDA UDI
Description
ISE Lithium Electrode for use with EasyElectrolyte Analyzers FDA UDI

Identifiers

Catalog Number
5205 FDA UDI
Primary DI / UDI-DI
00386100001667 FDA UDI
510(k) Number
K002407 FDA UDI
FDA Product Code
JIH FDA UDI
GMDN Term
Lithium electrode IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3560 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: Lithium electrode IVD

ISE Lithium Electrode by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lithium electrode IVD.

Cleared under the same submission

K002407 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medica Corp.

Sources (1)

  • FDA UDI 6830ea9f-4680-4fc9-8552-055ce5f8e0d9 37 fields · synced May 31, 2026