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Roche 9180 Potassium electrode

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
Roche 9180 Potassium electrode FDA UDI
Generic Name
Potassium (K+) IVD, kit, ion-selective electrode (ISE) FDA UDI
Model / Reference
03110338180 FDA UDI

Identifiers

Catalog Number
03110338180 FDA UDI
Primary DI / UDI-DI
04015630028689 FDA UDI
FDA Product Code
CEM FDA UDI
GMDN Term
Potassium (K+) IVD, kit, ion-selective electrode (ISE) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1600 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

No

FDA UDI

Category: Potassium (K+) IVD, kit, ion-selective electrode (ISE)

Roche 9180 Potassium electrode by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Potassium (K+) IVD, kit, ion-selective electrode (ISE).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI b01f5ad2-8b42-4ae5-9bd5-b7f5943f48c8 33 fields · synced May 31, 2026