Catalog Number

-

Brand Name

Resp-O2 Compact Compressor Nebulizer

Version/Model Number

34401

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

dc6b717b-c1fe-4af3-a630-f1ede99190b5

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 11, 2022

Package DI Number

00840117308725

Quantity per Package

6

Contains DI Package

00840117308718

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case