Catalog Number

5-200-0089

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

-

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

K954282

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

03fa41f6-be66-49f4-a4f0-772d9b0a412d

Public Version Date

July 22, 2019

Public Version Number

6

DI Record Publish Date

November 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-