Catalog Number

-

Brand Name

FACEFIT, NIV PORTED MASK, WITH ANTI-ASPHYXIATION VALVE AND CO2 LEAK PORT, MEDIUM

Version/Model Number

2251000

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K121747,K121747

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

d7d6c105-269e-47e1-b921-3c203db67210

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 06, 2021

Package DI Number

05030267089680

Quantity per Package

12

Contains DI Package

05030267080731

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-