Catalog Number

-

Brand Name

Nuby

Version/Model Number

719

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K023711,K023711,K023711

Product Code

PWN

Product Code Name

Baby Care Kit

Public Device Record Key

396de593-90e0-4c7d-9173-964decb697fb

Public Version Date

August 05, 2022

Public Version Number

5

DI Record Publish Date

March 23, 2017

Package DI Number

30048526007197

Quantity per Package

12

Contains DI Package

20048526007190

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-