Catalog Number

-

Brand Name

Heart® Direct Connect Continuous Nebulizer,Adult Kit

Version/Model Number

100619

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

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

-

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

38ddd7eb-fc96-47f5-8991-cb43fd10f7fb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 22, 2016

Package DI Number

10709078000116

Quantity per Package

18

Contains DI Package

00709078000119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-