Catalog Number

BRDT3854DM

Brand Name

Statcorp

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

d9e12c71-fd1f-47f0-8054-c06738d26c68

Public Version Date

August 28, 2019

Public Version Number

1

DI Record Publish Date

August 20, 2019

Package DI Number

30841522128572

Quantity per Package

5

Contains DI Package

10841522128578

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX