Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

HUM-TUB

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KFZ

Product Code Name

HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)

Public Device Record Key

1bb8d142-f1f0-412a-b23a-20b1d0c575be

Public Version Date

July 01, 2019

Public Version Number

1

DI Record Publish Date

June 21, 2019

Package DI Number

00822383527987

Quantity per Package

50

Contains DI Package

50822383527982

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-