Catalog Number

3-200-0041

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

Yes

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

K940214,K940214

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

84af910c-8b5d-4a26-a6a1-e15d5caa216f

Public Version Date

August 17, 2018

Public Version Number

5

DI Record Publish Date

April 04, 2018

Package DI Number

30841522123683

Quantity per Package

5

Contains DI Package

10841522123689

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BG