Catalog Number

-

Brand Name

DeVilbiss

Version/Model Number

DV5H-603

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"

Yes

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

-

Product Code

BZD

Product Code Name

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Public Device Record Key

9e2c0408-4009-4e8d-90f7-d6ad4a27a119

Public Version Date

February 17, 2020

Public Version Number

1

DI Record Publish Date

February 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-