Catalog Number

-

Brand Name

1BYONE

Version/Model Number

TMB-1585

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

K120058,K120058,K120058

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

41574f87-88ab-477a-b881-eb23561a047e

Public Version Date

June 05, 2020

Public Version Number

5

DI Record Publish Date

October 19, 2016

Package DI Number

00863696000316

Quantity per Package

1

Contains DI Package

00863696000309

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Giftbox