Catalog Number

-

Brand Name

Crosstex™ Isolator™ Molded N95 Surgical Respirator

Version/Model Number

GMLRESP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

K061375,K061375,K061375

Product Code

MSH

Product Code Name

Respirator, surgical

Public Device Record Key

d5eb3973-1cdf-4ced-9dd9-3c3c25c4553a

Public Version Date

October 17, 2022

Public Version Number

3

DI Record Publish Date

June 14, 2021

Package DI Number

50732224004698

Quantity per Package

12

Contains DI Package

10732224004690

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case