Kangaroo - CO2 Detector with Bellows - Cardinal Health, Inc.

Duns Number:080935429

Device Description: CO2 Detector with Bellows

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More Product Details

Catalog Number

777702

Brand Name

Kangaroo

Version/Model Number

777702

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K042572,K042572,K042572

Product Code Details

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Record Status

Public Device Record Key

b24e86a0-b41c-4b6b-bdcc-5f77ae3ddc8e

Public Version Date

June 05, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20884521000275

Quantity per Package

40

Contains DI Package

30884521000272

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