Catalog Number

-

Brand Name

Bello

Version/Model Number

AD715-BTWT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 27, 2020

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

PUH

Product Code Name

Analyzer, Body Composition, Exempt

Public Device Record Key

ea44178a-3a2e-4ece-996c-eaf558e02f28

Public Version Date

September 28, 2020

Public Version Number

2

DI Record Publish Date

January 01, 2020

Package DI Number

18800057400018

Quantity per Package

20

Contains DI Package

08800057400011

Package Discontinue Date

September 27, 2020

Package Status

Not in Commercial Distribution

Package Type

carton