WetAlert™ wireless wetness detector

FDA UDI

Class II (US FDA UDI)

by Fresenius Usa, Inc.

Identity

Trade Name: WetAlert™ wireless wetness detector FDA UDI
Generic Name: Haemodialysis system blood leak detector FDA UDI
Device Name: WetAlert™ wireless wetness detector FDA UDI
Model / Reference: 190507 FDA UDI
Description: WetAlert™ wireless wetness detector FDA UDI

Identifiers

Primary DI / UDI-DI: 00840861101023 FDA UDI
510(k) Number: K121421 FDA UDI
FDA Product Code: ONW FDA UDI
GMDN Term: Haemodialysis system blood leak detector FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5860 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

Yes

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

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Haemodialysis system blood leak detector

WetAlert™ wireless wetness detector by Fresenius Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis system blood leak detector.

Serim® GUARDIAN™ Blood Leak Test Strips — SERIM RESEARCH CORP. · Class II

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: Fresenius Usa, Inc.

Sources (1)

FDA UDI 4c3a170d-90db-437b-b446-c0b9120312fa 35 fields · synced Jun 1, 2026