CARDINAL HEALTH - CHART PAPER QUINTON INSTR 18416-001 - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: CHART PAPER QUINTON INSTR 18416-001

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More Product Details

Catalog Number

3687561

Brand Name

CARDINAL HEALTH

Version/Model Number

3687561

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"

Yes

For Single-Use

-

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

DSF

Product Code Name

RECORDER, PAPER CHART

Device Record Status

Public Device Record Key

fb2309ea-1591-4714-826b-dda595fba3ba

Public Version Date

July 03, 2019

Public Version Number

1

DI Record Publish Date

June 25, 2019

Additional Identifiers

Package DI Number

50885380019409

Quantity per Package

20

Contains DI Package

00885380019404

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 101686
2 A medical device with a moderate to high risk that requires special controls. 139430
3 A medical device with high risk that requires premarket approval 8
U Unclassified 40