Willow Breast Pump - Breast Pump - EXPLORAMED NC7, INC.

Duns Number:050917861

Device Description: Breast Pump

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More Product Details

Catalog Number

-

Brand Name

Willow Breast Pump

Version/Model Number

PDW00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 20, 2021

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"

-

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

HGX

Product Code Name

Pump, Breast, Powered

Device Record Status

Public Device Record Key

6516c57c-0abf-4561-8398-73ee48258a89

Public Version Date

September 01, 2022

Public Version Number

3

DI Record Publish Date

December 08, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EXPLORAMED NC7, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 57