Catalog Number

-

Brand Name

Amazfit

Version/Model Number

A2003

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

PUH

Product Code Name

Analyzer, Body Composition, Exempt

Public Device Record Key

017a2501-f456-44b7-a54a-5af5694b9431

Public Version Date

September 14, 2020

Public Version Number

1

DI Record Publish Date

September 04, 2020

Package DI Number

16971828190055

Quantity per Package

5

Contains DI Package

06971828190034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-