Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

MASK 001A

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

BYG

Product Code Name

MASK, OXYGEN

Public Device Record Key

3c6c1e14-297b-4ade-84af-34f9130cea96

Public Version Date

July 16, 2019

Public Version Number

4

DI Record Publish Date

May 19, 2017

Package DI Number

00822383127231

Quantity per Package

50

Contains DI Package

50822383127236

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-