Catalog Number

-

Brand Name

NA

Version/Model Number

2389

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"

-

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

K120125,K120125

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

67115bfd-1f57-4d6f-b375-568694fdb47b

Public Version Date

February 24, 2020

Public Version Number

5

DI Record Publish Date

June 24, 2016

Package DI Number

00840682120562

Quantity per Package

5

Contains DI Package

00840682119115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-