Catalog Number

UD3242MQ-05

Brand Name

Statcorp Medical

Version/Model Number

STATCORP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K954282

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

c86c8f04-12f4-43d3-83cb-14356eddfa2d

Public Version Date

June 08, 2021

Public Version Number

6

DI Record Publish Date

October 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-