Catalog Number

-

Brand Name

Beurer

Version/Model Number

PO60 (Art.-No.454.73)

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)

Yes

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

PGJ

Product Code Name

Oximeter, Wellness

Public Device Record Key

acb0bb71-4ac4-4256-8436-93b586076d38

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

May 08, 2017

Package DI Number

10853879007116

Quantity per Package

8

Contains DI Package

00853879007119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack