Catalog Number

-

Brand Name

Heart® Continuous Nebulizer Holder

Version/Model Number

100950

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

K923596,K923596

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

9437513e-842d-495f-a1d5-294307d6ec36

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 26, 2017

Package DI Number

10709078004831

Quantity per Package

1

Contains DI Package

00709078004834

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-