The First Years - Quiet Expressions Plus Rechargeable Pump - Double - TOMY INTERNATIONAL, INC.

Duns Number:065183758

Device Description: Quiet Expressions Plus Rechargeable Pump - Double

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More Product Details

Catalog Number

-

Brand Name

The First Years

Version/Model Number

Y6053

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

cdba8270-2652-4548-b8d6-d3e029cc6330

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 11, 2017

Additional Identifiers

Package DI Number

B268Y60531

Quantity per Package

1

Contains DI Package

B268Y60530

Package Discontinue Date

-

Package Status

-

Package Type

Retail/Master Ctn

"TOMY INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10