Catalog Number

-

Brand Name

Omada

Version/Model Number

BT104O

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

0ec46893-b26e-4db0-a4f2-9901f5482402

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

April 01, 2019

Package DI Number

B726BT104O2

Quantity per Package

5

Contains DI Package

B726BT104O1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5-­piece carton