Symphony Breast Milk Initiation Kit – Non Sterile - Breast pump kit - MEDELA, INC.

Duns Number:052002029

Device Description: Breast pump kit

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More Product Details

Catalog Number

-

Brand Name

Symphony Breast Milk Initiation Kit – Non Sterile

Version/Model Number

101041821

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

OHH

Product Code Name

Breast Pump Kit

Device Record Status

Public Device Record Key

c546da16-8e9b-460f-b2d3-c4989526e3d7

Public Version Date

November 09, 2020

Public Version Number

1

DI Record Publish Date

October 30, 2020

Additional Identifiers

Package DI Number

20020451418210

Quantity per Package

10

Contains DI Package

00020451418216

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDELA, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 244