DF365N95HC Respirator - Honeywell DF365N95HC Surgical N95 Respirator Mask - North Safety de Mexicali, S. de R. L. de C.V.

Duns Number:812503712

Device Description: Honeywell DF365N95HC Surgical N95 Respirator Mask w/ Nose clip

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More Product Details

Catalog Number

-

Brand Name

DF365N95HC Respirator

Version/Model Number

DF365N95HC

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

8a709452-ff87-47d4-ab3b-a4d6b8057ed1

Public Version Date

September 01, 2022

Public Version Number

1

DI Record Publish Date

August 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORTH SAFETY DE MEXICALI, S. DE R. L. DE C.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 1