Catalog Number

-

Brand Name

1BYONE

Version/Model Number

TMB-1585-BS

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

4cfdb5db-92c9-4b6e-bbc7-9b63409f0989

Public Version Date

June 05, 2020

Public Version Number

2

DI Record Publish Date

November 11, 2019

Package DI Number

10850014261013

Quantity per Package

20

Contains DI Package

00850014261016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer carton