← Back to catalogue

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 FABRIC,1T,LG.ADULT,32-42CM,MQ FDA UDI
Model / Reference
SoftCheck BP Cuffs FDA UDI
Description
BP CUFF,SC FABRIC,1T,LG.ADULT,32-42CM,MQ FDA UDI

Identifiers

Catalog Number
ST3242MQ FDA UDI
Primary DI / UDI-DI
10841522109485 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Cleared under the same submission

K940214 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Statcorp Medical

Sources (1)

  • FDA UDI 1defed35-42f9-4648-8d37-08c75b6cc9ec 38 fields · synced Jun 8, 2026