Catalog Number

53037-12

Brand Name

Axess Mask, Small Bubblegum, 24 Pk

Version/Model Number

53037-12

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

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

KHA

Product Code Name

Mask, Scavenging

Public Device Record Key

837f0764-c474-4d46-8b23-3d9994610d42

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-