Catalog Number

-

Brand Name

Symphony Single Kit-Sterile

Version/Model Number

67026S

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

dabe6aff-b61c-4db9-ba35-8a153c4d8c8c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 12, 2016

Package DI Number

20020451000545

Quantity per Package

24

Contains DI Package

00020451000411

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton