Catalog Number

3655I-AR

Brand Name

DeVilbiss

Version/Model Number

3655I

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

Product Code

BTI

Product Code Name

Compressor, Air, Portable

Public Device Record Key

aac0e613-999c-42f3-bb38-75ef39299e7c

Public Version Date

December 11, 2020

Public Version Number

4

DI Record Publish Date

April 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-