MEDI-VAC - 1000cc Flex Can S/Strt Conn - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: 1000cc Flex Can S/Strt Conn

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More Product Details

Catalog Number

65652-613

Brand Name

MEDI-VAC

Version/Model Number

65652-613

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 22, 2016

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

GCX

Product Code Name

APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Device Record Status

Public Device Record Key

39218e66-74a9-48f6-8506-4cf5a11b5f94

Public Version Date

January 08, 2021

Public Version Number

8

DI Record Publish Date

July 22, 2016

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