Catalog Number

3655PL-ME

Brand Name

DeVilbiss

Version/Model Number

3655PL-ME

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

-

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

K020932,K020932

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

fed1d5b2-ed1a-4a86-b907-7dd81c766974

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 08, 2016

Package DI Number

10885304001536

Quantity per Package

6

Contains DI Package

00885304001539

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case