NA - Ezee Nest Smpl Cup Roche - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Ezee Nest Smpl Cup Roche

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More Product Details

Catalog Number

4095000

Brand Name

NA

Version/Model Number

4095000

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KYW

Product Code Name

CONTAINER, LIQUID MEDICATION, GRADUATED

Device Record Status

Public Device Record Key

e1dc8240-a5b2-4204-aa51-7dd7a2e05d72

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 27, 2018

Additional Identifiers

Package DI Number

20884521162010

Quantity per Package

5000

Contains DI Package

10884521162013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 672
2 A medical device with a moderate to high risk that requires special controls. 1692
U Unclassified 17