Catalog Number

-

Brand Name

Pasture F550G Respirator

Version/Model Number

F550G

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083176,K083176

Product Code

NZJ

Product Code Name

Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

Public Device Record Key

6b02099b-5727-4d7d-a8ac-a557f7bbcf58

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

January 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-