Catalog Number

-

Brand Name

MC 300* Nebulizer with Universal Tubing

Version/Model Number

105554

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

K173367,K173367

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

7c96f198-d2f3-4981-9f0b-18cbbce0f4f2

Public Version Date

February 27, 2020

Public Version Number

1

DI Record Publish Date

February 19, 2020

Package DI Number

10762860055541

Quantity per Package

50

Contains DI Package

00762860055544

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-