Catalog Number

-

Brand Name

BWELL

Version/Model Number

EF-919B4

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)

-

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

8a03f918-1dba-48ef-82a1-d506e7fa0999

Public Version Date

April 29, 2021

Public Version Number

1

DI Record Publish Date

April 21, 2021

Package DI Number

16947468500189

Quantity per Package

1

Contains DI Package

06947468500182

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

1pcs/box