Catalog Number

1130733

Brand Name

SimplyGo Mini

Version/Model Number

SimplyGo Mini with Extended Battery, BR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 05, 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

K111885

Product Code

CAW

Product Code Name

Generator, oxygen, portable

Public Device Record Key

242d0290-6a79-4efa-a1e7-4a6e3fafce50

Public Version Date

March 05, 2021

Public Version Number

5

DI Record Publish Date

April 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-