Softcheck

FDA UDI

Class II (US FDA UDI)

by Statcorp Medical

Identity

Trade Name: Softcheck FDA UDI
Generic Name: Blood pressure cuff, single-use FDA UDI
Device Name: BP CUFF,SC VINYL,1T,LG.ADULT,32-42CM,ML, EA FDA UDI
Model / Reference: SoftCheck BP Cuffs FDA UDI
Description: BP CUFF,SC VINYL,1T,LG.ADULT,32-42CM,ML, EA FDA UDI

Identifiers

Catalog Number: VST3242ML FDA UDI
Primary DI / UDI-DI: 10841522112034 FDA UDI
510(k) Number: K940214 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

Softcheck by Statcorp Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood pressure cuff, single-use.

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Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C. · Class II
MEDLINE INDUSTRIES, INC. — MEDLINE INDUSTRIES, INC. · Class II
Orantech — Orantech Inc. · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II

Cleared under the same submission

K940214 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: Statcorp Medical

Sources (1)

FDA UDI 78b56253-9894-41bd-9c75-b56576d1c881 37 fields · synced May 31, 2026