Catalog Number

3-200-0043

Brand Name

Statcorp Medical

Version/Model Number

STATCORP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2017

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

K940214,K940214

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

725e5e27-136b-4081-9609-dc5d9e6a4c9a

Public Version Date

July 30, 2018

Public Version Number

4

DI Record Publish Date

December 05, 2016

Package DI Number

30841522100868

Quantity per Package

5

Contains DI Package

10841522100864

Package Discontinue Date

December 31, 2017

Package Status

Not in Commercial Distribution

Package Type

BG