NOVAPLUS - Underpad Extra Moderate - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Underpad Extra Moderate

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More Product Details

Catalog Number

V949B10

Brand Name

NOVAPLUS

Version/Model Number

V949B10

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

KME

Product Code Name

BEDDING, DISPOSABLE, MEDICAL

Device Record Status

Public Device Record Key

c98eedba-91e5-4e88-b775-6cba2d92444b

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 30, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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