Catalog Number

-

Brand Name

1 BY ONE

Version/Model Number

9-JK14US06

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

f38ba816-c093-4b4d-a6ef-684898ff0dcd

Public Version Date

June 16, 2020

Public Version Number

1

DI Record Publish Date

June 08, 2020

Package DI Number

00858069007177

Quantity per Package

1

Contains DI Package

00858069007153

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

gift box