CARDINAL HEALTH - Medi-Vac Coiled Non-Conductive Connecting Tubes - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Medi-Vac Coiled Non-Conductive Connecting Tubes

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More Product Details

Catalog Number

FG71-2385A

Brand Name

CARDINAL HEALTH

Version/Model Number

FG71-2385A

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

GAZ

Product Code Name

TUBING, NONINVASIVE

Device Record Status

Public Device Record Key

e59d8837-2af8-480c-953b-667abc0d4ba7

Public Version Date

May 31, 2022

Public Version Number

1

DI Record Publish Date

May 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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