Catalog Number

-

Brand Name

AEROECLIPSE II Breath Actuated Nebulizer Disposable

Version/Model Number

105501

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

-

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

K053605,K053605,K053605

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

8dd312e6-3264-4deb-9b8c-ae6a8d14cb5c

Public Version Date

February 26, 2020

Public Version Number

1

DI Record Publish Date

February 18, 2020

Package DI Number

10762860055015

Quantity per Package

50

Contains DI Package

00762860055018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-