Catalog Number

-

Brand Name

Drive

Version/Model Number

MQ8000

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

Yes

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

CAF

Product Code Name

NEBULIZER (DIRECT PATIENT INTERFACE)

Public Device Record Key

0e290bd6-df6b-4bb9-87a2-f75d480d9a32

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

10822383579259

Quantity per Package

20

Contains DI Package

00822383579252

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-