Catalog Number

-

Brand Name

Sklar®

Version/Model Number

06-2666

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K080189

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

6d45c0ed-2ab3-46ec-a353-ce4a49ceb3db

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

March 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-