Catalog Number

-

Brand Name

Swing Maxi

Version/Model Number

101043614

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K210759

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

fc943796-438b-4548-bab7-be5dad119fac

Public Version Date

September 28, 2021

Public Version Number

1

DI Record Publish Date

September 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-