Catalog Number

015-4250

Brand Name

STATCORP MEDICAL

Version/Model Number

STATCORP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 15, 2018

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152801,K152801

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

e3d37e42-db5b-443a-a12e-4212ec219125

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

March 06, 2017

Package DI Number

30841522102602

Quantity per Package

20

Contains DI Package

10841522102608

Package Discontinue Date

May 15, 2018

Package Status

Not in Commercial Distribution

Package Type

BX