Catalog Number

1020010

Brand Name

EverFlo

Version/Model Number

EverFlo w/Oxygen Percentage Indicator, 230V, AU

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 9999

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

97b78724-ea5f-46ab-96c5-a972836c395c

Public Version Date

January 26, 2021

Public Version Number

4

DI Record Publish Date

January 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-