Catalog Number

1020020

Brand Name

EverFlo

Version/Model Number

EVERFLO w/Oxygen Percentage Indicator, 230V, CN

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2021

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

K061261

Product Code

CAW

Product Code Name

Generator, oxygen, portable

Public Device Record Key

8eb0d815-41df-4a9d-8e1f-2c80c5ab9a57

Public Version Date

March 01, 2021

Public Version Number

5

DI Record Publish Date

January 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-