Catalog Number

-

Brand Name

Crosstex™ Isolator™ Duckbill N95 Surgical Respirator

Version/Model Number

GDBRESP

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

-

Product Code

MSH

Product Code Name

Respirator, surgical

Public Device Record Key

2c5c86eb-30cc-4073-9c1a-5dde7762eab9

Public Version Date

October 14, 2021

Public Version Number

2

DI Record Publish Date

September 01, 2021

Package DI Number

50732224004919

Quantity per Package

4

Contains DI Package

10732224004911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case