ARES 610 Home Sleep Test Accessories - 10 pack

FDA UDI

Class II (US FDA UDI)

by WATERMARK MEDICAL Inc

Identity

Trade Name: ARES 610 Home Sleep Test Accessories - 10 pack FDA UDI
Generic Name: Skin-cleaning wipe, sterile FDA UDI
Device Name: ARES 610 HST Disposables x10 FDA UDI
Model / Reference: 610 FDA UDI
Description: ARES 610 HST Disposables x10 FDA UDI

Identifiers

Catalog Number: WMDK-001 FDA UDI
Primary DI / UDI-DI: 00854485007104 FDA UDI
510(k) Number: K110705 FDA UDI
K111194 FDA UDI
K112514 FDA UDI
FDA Product Code: NFB FDA UDI
ETN FDA UDI
GMDN Term: Skin-cleaning wipe, sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5905 FDA UDI
874.1820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Category: Nasal oxygen cannula, basic Analytical non-scalp cutaneous electrode Skin-cleaning wipe, sterile

ARES 610 Home Sleep Test Accessories - 10 pack by WATERMARK MEDICAL Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K110705 also covers:

K111194 also covers:

K112514 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: WATERMARK MEDICAL Inc

Sources (1)

FDA UDI c1c19666-e1d0-4b65-bbd6-905ba66f6e5c 37 fields · synced Jun 6, 2026