Catalog Number

715-1165-10

Brand Name

Statcorp Medical

Version/Model Number

STATCORP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 29, 2019

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

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

d16be708-070a-47b0-bf65-d3fce8865857

Public Version Date

July 01, 2019

Public Version Number

4

DI Record Publish Date

November 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-