Catalog Number

525DS

Brand Name

DeVilbiss

Version/Model Number

525DS

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

K071397

Product Code

CAW

Product Code Name

Generator, Oxygen, Portable

Public Device Record Key

13a0b017-97c7-489e-aa6c-222fee15f5a2

Public Version Date

December 11, 2020

Public Version Number

4

DI Record Publish Date

November 06, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-