Catalog Number

3655SE

Brand Name

DeVilbiss

Version/Model Number

3655SE

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

BTI

Product Code Name

Compressor, Air, Portable

Public Device Record Key

10f7ae52-6863-4793-8924-36ac7a76bb07

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 08, 2016

Package DI Number

10885304002311

Quantity per Package

6

Contains DI Package

00885304002314

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case