Catalog Number

C801AT

Brand Name

Omron Air Tube

Version/Model Number

C801AT

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

K110860,K110860

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

374755b7-fbfe-439d-a7ad-ef2917997edb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 17, 2017

Package DI Number

10073796801103

Quantity per Package

100

Contains DI Package

00073796801106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case