Catalog Number

-

Brand Name

Elite Compressor Nebulizer

Version/Model Number

5605

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K091272,K091272

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

736825c0-abf5-4a78-8535-0826360d33d2

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

00616784560533

Quantity per Package

4

Contains DI Package

00616784560519

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-