Catalog Number

42361

Brand Name

Barrier

Version/Model Number

42361-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K934194,K934194,K934194

Product Code

FXX

Product Code Name

Mask, surgical

Public Device Record Key

b766def8-7f2f-4b6b-8e5f-aca64cd00aba

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

September 17, 2016

Package DI Number

07323190000524

Quantity per Package

10

Contains DI Package

07323190000531

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-