Catalog Number

-

Brand Name

AEROECLIPSE XL Reusable Breath Actuated Nebulizer

Version/Model Number

105513

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

K080926,K080926,K080926,K080926

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

baf6375f-fcc6-4f11-bd82-3719bae170b8

Public Version Date

December 01, 2021

Public Version Number

2

DI Record Publish Date

February 19, 2020

Package DI Number

10762860055138

Quantity per Package

10

Contains DI Package

00762860055131

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-