KIMBERLY-CLARK® N95 Particulate Filter Respirator and Surgical Mask - N95 Particulate Filter Respirator and Surgical - KIMBERLY-CLARK GLOBAL SALES, LLC

Duns Number:830997032

Device Description: N95 Particulate Filter Respirator and Surgical Mask

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More Product Details

Catalog Number

-

Brand Name

KIMBERLY-CLARK® N95 Particulate Filter Respirator and Surgical Mask

Version/Model Number

46867

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

MSH

Product Code Name

Respirator,surgical

Device Record Status

Public Device Record Key

dd625e0d-1c32-4801-b26e-2152ae2584c2

Public Version Date

May 06, 2020

Public Version Number

3

DI Record Publish Date

November 30, 2016

Additional Identifiers

Package DI Number

10036000468677

Quantity per Package

6

Contains DI Package

00036000468670

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"KIMBERLY-CLARK GLOBAL SALES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1