Catalog Number

-

Brand Name

1 BY ONE

Version/Model Number

703NA-0005

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

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

1b0c2daa-790a-4915-8a5e-d312890e8193

Public Version Date

July 07, 2020

Public Version Number

1

DI Record Publish Date

June 29, 2020

Package DI Number

00858069007221

Quantity per Package

1

Contains DI Package

00858069007207

Package Discontinue Date

June 29, 2020

Package Status

Not in Commercial Distribution

Package Type

inner case