Catalog Number

3655PL-JCMH

Brand Name

DeVilbiss

Version/Model Number

3655PL-JCMH

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 09, 2016

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

3a180883-dae7-4011-a897-0196abb23655

Public Version Date

June 23, 2020

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-