Catalog Number

UD2938DM

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,K954282

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

d57d8ea6-b2b0-47ba-9eb8-7b2fea286037

Public Version Date

June 08, 2021

Public Version Number

8

DI Record Publish Date

December 12, 2016

Package DI Number

30841522100332

Quantity per Package

5

Contains DI Package

10841522100338

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BG