Catalog Number

-

Brand Name

Escali

Version/Model Number

BFBW180

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

Yes

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

5fbedb36-4e4d-4dcd-be00-697633d20d19

Public Version Date

December 05, 2019

Public Version Number

1

DI Record Publish Date

November 27, 2019

Package DI Number

00854202006519

Quantity per Package

4

Contains DI Package

00854202006502

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton