Catalog Number

101037319

Brand Name

Sonata Breastpump

Version/Model Number

Sonata Deluxe

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"

Yes

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

K161725,K161725

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

5ede8cc7-5dc1-4f4a-b0bb-8d4dd3d5f517

Public Version Date

July 01, 2019

Public Version Number

1

DI Record Publish Date

June 21, 2019

Package DI Number

10020451367504

Quantity per Package

1

Contains DI Package

00020451367507

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton