Na Electrode, Ise Module

FDA UDI

Class II (US FDA UDI)

by Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Identity

Trade Name: NA ELECTRODE, ISE MODULE FDA UDI
Generic Name: Sodium (Na+) electrode IVD FDA UDI
Device Name: Clinical Chemistry Test Systems / Sodium test system. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. FDA UDI
Model / Reference: NA+ Electrode FDA UDI
Description: Clinical Chemistry Test Systems / Sodium test system. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. FDA UDI

Identifiers

Catalog Number: 5201 FDA UDI
Primary DI / UDI-DI: 05999883586686 FDA UDI
510(k) Number: K101741 FDA UDI
FDA Product Code: JGS FDA UDI
GMDN Term: Sodium (Na+) electrode IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1665 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Height — 60 Millimeter FDA UDI
Depth — 40 Millimeter FDA UDI
Width — 90 Millimeter FDA UDI

Category: Sodium (Na+) electrode IVD

Na Electrode, Ise Module by Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag — Class II — FDA…

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Sodium Electrode — Roche Diagnostics Corp. · Class II
i-STAT — Abbott Point of Care Inc. · Class II
ISE Sodium Electrode — Roche Diagnostics Corp. · Class II
RAPIDChem® 700 RAPIDPoint® 350 Sodium Sensor — Siemens Healthcare Diagnostics · Class II

Cleared under the same submission

K101741 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: Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Sources (1)

FDA UDI 574916fc-a365-403c-8185-7c4f8a323d42 38 fields · synced Jun 6, 2026