CARDINAL HEALTH - NPWT Y Connector Occlusion Detection - CARDINAL HEALTH 200, LLC

Duns Number:112164780

Device Description: NPWT Y Connector Occlusion Detection

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More Product Details

Catalog Number

48-2500

Brand Name

CARDINAL HEALTH

Version/Model Number

48-2500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

Yes

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

OMP

Product Code Name

negative pressure wound therapy Powered suction pump

Device Record Status

Public Device Record Key

20f4aba9-f2d9-47c6-8cf9-2071e60377b5

Public Version Date

October 19, 2020

Public Version Number

2

DI Record Publish Date

November 12, 2019

Additional Identifiers

Package DI Number

50885380153141

Quantity per Package

10

Contains DI Package

10885380153143

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 81
2 A medical device with a moderate to high risk that requires special controls. 111