Catalog Number

-

Brand Name

1BYONE

Version/Model Number

TMB-1585-BT

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

K131395,K131395,K131395

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

bdb584dd-ac80-40ce-8eab-82d6f280a683

Public Version Date

June 05, 2020

Public Version Number

5

DI Record Publish Date

August 28, 2017

Package DI Number

10858069007044

Quantity per Package

20

Contains DI Package

00858069007047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER CARTON