Catalog Number

Type BC80

Brand Name

Beurer

Version/Model Number

BC81

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

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

32a2810c-392a-40be-bd34-6a89e37c6608

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

October 18, 2016

Package DI Number

20852547004645

Quantity per Package

4

Contains DI Package

10852547004648

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack