Omron Digital Weight Scale - Omron Digital Weight Scale Telehealth with - Omron Healthcare, Inc.

Duns Number:054318779

Device Description: Omron Digital Weight Scale Telehealth with Bluetooth - 20-550 lbs.

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More Product Details

Catalog Number

HN-290T

Brand Name

Omron Digital Weight Scale

Version/Model Number

HN-290T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FRI

Product Code Name

Scale, Stand-On, Patient

Device Record Status

Public Device Record Key

38b93015-e8a7-47cd-bad9-558b10325488

Public Version Date

February 09, 2021

Public Version Number

1

DI Record Publish Date

February 01, 2021

Additional Identifiers

Package DI Number

10073796842908

Quantity per Package

3

Contains DI Package

00073796842901

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"OMRON HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 48