Catalog Number

-

Brand Name

Easivent Mask - Small

Version/Model Number

49502-208-01

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K981167,K981167

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

fef98e29-3d21-4656-9f2f-6c762e45d5ef

Public Version Date

January 21, 2022

Public Version Number

6

DI Record Publish Date

April 10, 2018

Package DI Number

30349502208011

Quantity per Package

10

Contains DI Package

00349502208010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case