Catalog Number

166100

Brand Name

Nebulizer, Hand Held, Tee Adapter, 84" Tube

Version/Model Number

Nebulizer, Hand Held, Tee Adapter, 84" Tube - 166100

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

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

-

Product Code

EPN

Product Code Name

Pump, Nebulizer, Manual

Public Device Record Key

cd9f93e4-f9f0-4cc4-ade2-4e4dfaf1614d

Public Version Date

April 14, 2020

Public Version Number

1

DI Record Publish Date

April 06, 2020

Package DI Number

00817081026313

Quantity per Package

50

Contains DI Package

00817081026306

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-