Symphony Breast Pump Kit - Breastpump Kit. - MEDELA, INC.

Duns Number:052002029

Device Description: Breastpump Kit.

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More Product Details

Catalog Number

-

Brand Name

Symphony Breast Pump Kit

Version/Model Number

101040420

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

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 Details

Product Code

OHH

Product Code Name

Breast Pump Kit

Device Record Status

Public Device Record Key

45da7feb-2235-4694-907e-15ff92cb099e

Public Version Date

March 05, 2021

Public Version Number

1

DI Record Publish Date

February 25, 2021

Additional Identifiers

Package DI Number

10020451404209

Quantity per Package

10

Contains DI Package

00020451404202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"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