Catalog Number

2010X

Brand Name

Tech-Med

Version/Model Number

2010X

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

62b6c52d-becb-491a-a770-db0e681dfa20

Public Version Date

May 23, 2022

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20665973017000

Quantity per Package

24

Contains DI Package

10665973017003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Casa