Catalog Number

2010

Brand Name

Tech-Med

Version/Model Number

2010

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K780715,K780715,K780715

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

3d5c26f0-eea6-4e37-83e7-bf2cf3e91149

Public Version Date

May 23, 2022

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20665973016911

Quantity per Package

24

Contains DI Package

10665973016914

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case