Catalog Number

-

Brand Name

EZflow

Version/Model Number

10-32001

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

K990384,K990384

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

9f03c4f6-cb58-4778-99a4-1942c69ec43b

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

March 07, 2016

Package DI Number

30641043320017

Quantity per Package

25

Contains DI Package

10641043320013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-