Nature's Bond - Premium Breastfeeding Pump - OAKWELL DISTRIBUTION, INC.

Duns Number:033337813

Device Description: Premium Breastfeeding Pump

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More Product Details

Catalog Number

-

Brand Name

Nature's Bond

Version/Model Number

603

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K142168,K142168

Product Code Details

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Device Record Status

Public Device Record Key

c6835c0b-20fa-4e48-924d-c9fe60c08766

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 31, 2016

Additional Identifiers

Package DI Number

10879766003597

Quantity per Package

2

Contains DI Package

00879766003590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"OAKWELL DISTRIBUTION, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 64