Catalog Number

28534

Brand Name

Sample Pack, Axess Mask 3 Pcs

Version/Model Number

28534

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 14, 2199

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

-

Product Code

KHA

Product Code Name

Mask, Scavenging

Public Device Record Key

1a944be4-38d7-4e08-b8e8-f83441d565e6

Public Version Date

January 14, 2019

Public Version Number

1

DI Record Publish Date

December 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-