Catalog Number

-

Brand Name

Beurer

Version/Model Number

IH50

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

3db9bf8c-a20e-4ef9-87c5-eb8ffc5c2650

Public Version Date

November 30, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

20852547004058

Quantity per Package

4

Contains DI Package

10852547004051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack