Catalog Number

-

Brand Name

Aerogen® Solo; Aerogen Ultra

Version/Model Number

90-096

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 24, 2020

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K133360

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

8a374165-d44a-4168-8994-e416ac722458

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-