Catalog Number

-

Brand Name

Pedi-Neb Nasal Nebulizer

Version/Model Number

0383

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"

Yes

For Single-Use

Yes

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

K800562,K800562

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

c607878b-0e0e-457a-ad1e-ef20ec1dabfb

Public Version Date

July 09, 2020

Public Version Number

4

DI Record Publish Date

November 24, 2016

Package DI Number

10709078001595

Quantity per Package

12

Contains DI Package

00709078001598

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-