Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

18081-OXYLIFE

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

K161586,K161586

Product Code

CAF

Product Code Name

NEBULIZER (DIRECT PATIENT INTERFACE)

Public Device Record Key

95a10399-cc50-4b18-8011-1a93067489e8

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

50822383569128

Quantity per Package

6

Contains DI Package

00822383569123

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-