Catalog Number

S5200

Brand Name

Schuco

Version/Model Number

S5200

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

K043238,K043238

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

a7daa2f1-0162-4abc-9cb9-4da88d438de2

Public Version Date

May 12, 2020

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

40026072011704

Quantity per Package

6

Contains DI Package

00026072011706

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case