Catalog Number

-

Brand Name

DART

Version/Model Number

DART140

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

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

CCQ

Product Code Name

Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Public Device Record Key

8ddcd0e2-5d5c-4391-80af-ec009e763ea2

Public Version Date

April 04, 2022

Public Version Number

1

DI Record Publish Date

March 25, 2022

Package DI Number

10841470100671

Quantity per Package

25

Contains DI Package

00841470100674

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-