Catalog Number

-

Brand Name

microlife

Version/Model Number

Office AFIB

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

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

efca116e-ae8e-424f-a0d1-84763250552d

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

May 19, 2017

Package DI Number

16970388160102

Quantity per Package

8

Contains DI Package

06970388160105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton packing