Catalog Number

-

Brand Name

Fitreno

Version/Model Number

B22

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

K172171,K172171

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

feb2e7ce-9427-4f76-976c-42a71b4677d5

Public Version Date

September 15, 2020

Public Version Number

1

DI Record Publish Date

September 07, 2020

Package DI Number

16927709442157

Quantity per Package

30

Contains DI Package

06927709442150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-