MC 300*R Nebulizer with Mouthpiece - MC 300* Reusable Nebulizer with Mouthpiece - Trudell Medical International

Duns Number:203298203

Device Description: MC 300* Reusable Nebulizer with Mouthpiece

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More Product Details

Catalog Number

10555294050

Brand Name

MC 300*R Nebulizer with Mouthpiece

Version/Model Number

105552

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 2020

Issuing Agency

In GS1

Product Characteristics

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

K173825,K173825

Product Code Details

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Device Record Status

Public Device Record Key

b85d0473-2b19-4660-a03a-d8f8c35b7f19

Public Version Date

April 23, 2020

Public Version Number

3

DI Record Publish Date

June 29, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRUDELL MEDICAL INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 21