Catalog Number

10551394050

Brand Name

AEROECLIPSE* XL Reusable Breath Actuated Nebulizer

Version/Model Number

105513

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 2020

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

K080926,K080926

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

254ec364-2742-40f5-b4b9-5553b5d05e9f

Public Version Date

April 23, 2020

Public Version Number

3

DI Record Publish Date

June 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-