Advanced Double Electric Breast Pump - Evenflo Feeding, Inc. Advanced Double Electric - EVENFLO FEEDING, INC.

Duns Number:078611319

Device Description: Evenflo Feeding, Inc. Advanced Double Electric Breast Pump

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More Product Details

Catalog Number

-

Brand Name

Advanced Double Electric Breast Pump

Version/Model Number

2951

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K131153

Product Code Details

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Device Record Status

Public Device Record Key

5d2d1935-72d6-4231-a99b-e209d8e19d1a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EVENFLO FEEDING, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3