Catalog Number

177-124

Brand Name

Aerotech I Radioaerosol Administration System

Version/Model Number

177-124

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K800023,K800023,K800023,K800023

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

dc9d8b5b-8213-444c-b6ed-1b0ecd2d24f6

Public Version Date

September 06, 2018

Public Version Number

4

DI Record Publish Date

December 18, 2017

Package DI Number

30718175001272

Quantity per Package

25

Contains DI Package

00718175001240

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box