Catalog Number

Art.- No. 454.71

Brand Name

Beurer

Version/Model Number

PO30

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

PGJ

Product Code Name

Oximeter, Wellness

Public Device Record Key

135eff8b-9ff4-410f-af9c-9d533d83f037

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

November 30, 2017

Package DI Number

10852547004211

Quantity per Package

8

Contains DI Package

00852547004214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack