Thora-Seal - Replacement Collection Chamber,Three Chamber - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Replacement Collection Chamber,Three Chamber System

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More Product Details

Catalog Number

8884713900

Brand Name

Thora-Seal

Version/Model Number

8884713900

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)

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

KDQ

Product Code Name

BOTTLE, COLLECTION, VACUUM

Device Record Status

Public Device Record Key

c3540d6c-2d87-4546-80f0-3ca75faa3cc8

Public Version Date

January 08, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20884521101125

Quantity per Package

6

Contains DI Package

10884521101128

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