Nuby - LUV N' CARE, LTD.

Duns Number:108926288

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More Product Details

Catalog Number

-

Brand Name

Nuby

Version/Model Number

509

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)

-

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

KKO

Product Code Name

Ring, Teething, Fluid-Filled

Device Record Status

Public Device Record Key

8386c25b-89dd-435c-8d56-7507b8d833c5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 01, 2016

Additional Identifiers

Package DI Number

50048526005098

Quantity per Package

12

Contains DI Package

40048526005091

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"LUV N' CARE, LTD." 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. 12