Catalog Number

-

Brand Name

Symphony Breastmilk Initiation Kit-Sterile

Version/Model Number

67350S

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

Yes

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

-

Product Code

OHH

Product Code Name

Breast Pump Kit

Public Device Record Key

2e829c97-9f99-47c8-b163-4ab1099c47e1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 12, 2016

Package DI Number

10020451673506

Quantity per Package

10

Contains DI Package

00020451673509

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton