Catalog Number

C28FL

Brand Name

Omron Air Filters for NE-C28

Version/Model Number

C28FL

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

K060811,K060811,K060811,K060811

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

76ac6541-de15-4749-bb1e-674ec7d50a45

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

May 17, 2017

Package DI Number

10073796328624

Quantity per Package

50

Contains DI Package

00073796328627

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton