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Statcorp Medical

FDA UDI

Class II (US FDA UDI)

by Statcorp Medical

Identity

Trade Name
Statcorp Medical FDA UDI
Generic Name
Blood pressure cuff, single-use FDA UDI
Device Name
BP CUFF,SC FREE NEO,1T,SIZE 3,6-11CM,M316 FDA UDI
Model / Reference
STATCORP FDA UDI
Description
BP CUFF,SC FREE NEO,1T,SIZE 3,6-11CM,M316 FDA UDI

Identifiers

Catalog Number
N/A FDA UDI
Primary DI / UDI-DI
10841522110054 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

No

FDA UDI

Statcorp Medical 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

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Manufacturer

Manufacturer
Statcorp Medical

Sources (1)

  • FDA UDI 8a1298e5-3635-42a2-a3ad-e47456773948 37 fields · synced Jun 6, 2026