ri-gital®, digital thermometer incl. button cell battery

FDA UDI

Class II (US FDA UDI)

by Rudolf Riester GmbH & Co. KG

Identity

Trade Name: ri-gital®, digital thermometer incl. button cell battery FDA UDI
Generic Name: Intermittent electronic patient thermometer FDA UDI
Device Name: The thermometers are for measuring the body temperature. FDA UDI
Model / Reference: 1850 FDA UDI
Description: The thermometers are for measuring the body temperature. FDA UDI

Identifiers

Catalog Number: 1850 FDA UDI
Primary DI / UDI-DI: 04045396002722 FDA UDI
510(k) Number: K851146 FDA UDI
FDA Product Code: FLL FDA UDI
GMDN Term: Intermittent electronic patient thermometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2910 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intermittent electronic patient thermometer

ri-gital®, digital thermometer incl. button cell battery by Rudolf Riester GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

K851146 also covers:

Kaz — KAZ USA, INC.
Vicks — KAZ USA, INC.
Vicks — KAZ USA, INC.
The First Years — TOMY International, Inc.
The First Years — TOMY International, Inc.

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: Rudolf Riester GmbH & Co. KG

Sources (1)

FDA UDI 9a5396d9-2138-48f0-9278-b300428b7789 35 fields · synced May 30, 2026