Catalog Number

-

Brand Name

Commander Flex™

Version/Model Number

101001-002

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

K091821

Product Code

DXN

Product Code Name

System, measurement, blood-pressure, non-invasive

Public Device Record Key

8abb1bfb-952a-42f0-8362-e2caf395438e

Public Version Date

October 10, 2022

Public Version Number

3

DI Record Publish Date

July 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-