Radius VSM

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name: Radius VSM FDA UDI
Generic Name: Blood pressure cuff, single-use FDA UDI
Device Name: Radius VSM Disposable NIBP Cuff, Adult, 20/box FDA UDI
Model / Reference: 4826 FDA UDI
Description: Radius VSM Disposable NIBP Cuff, Adult, 20/box FDA UDI

Identifiers

Primary DI / UDI-DI: 10843997006993 FDA UDI
510(k) Number: K223498 FDA UDI
FDA Product Code: DXQ FDA UDI
GMDN Term: Blood pressure cuff, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1120 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

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: Blood pressure cuff, single-use

Radius VSM by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Blood pressure cuff, single-use.

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MEDLINE INDUSTRIES, INC. — MEDLINE INDUSTRIES, INC. · Class II

Cleared under the same submission

K223498 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: Masimo Corporation

Sources (1)

FDA UDI 348ff702-f80a-4b6a-a0b8-df29c28cf8fd 36 fields · synced Jun 1, 2026