Catalog Number

10555794050

Brand Name

MC300® Nebulizer with Corrugated Tubing, Mouthpiece and Universal Tubing

Version/Model Number

105557

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

-

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

K203400,K203400

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

998b7571-1368-4f79-99f3-77ab4696d038

Public Version Date

June 29, 2021

Public Version Number

1

DI Record Publish Date

June 21, 2021

Package DI Number

10762860055572

Quantity per Package

50

Contains DI Package

00762860055575

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-