Catalog Number

SC-150

Brand Name

Omron Scale with Bluetooth

Version/Model Number

SC-150

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FRI

Product Code Name

Scale, Stand-On, Patient

Public Device Record Key

8d81a23a-7d00-4760-a654-de71fb33d82c

Public Version Date

June 09, 2021

Public Version Number

1

DI Record Publish Date

June 01, 2021

Package DI Number

10073796931503

Quantity per Package

6

Contains DI Package

00073796931506

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case