Kendall - DL Disposable Cable and Lead Wire System,5 Lead - Cardinal Health, Inc.

Duns Number:080935429

Device Description: DL Disposable Cable and Lead Wire System,5 Lead Dual Connect, Adapter Required

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More Product Details

Catalog Number

33135

Brand Name

Kendall

Version/Model Number

33135

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

IKD

Product Code Name

CABLE, ELECTRODE

Device Record Status

Public Device Record Key

c5a9c7f2-5a98-4cda-9ef8-707d9b1ef44e

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20884527021793

Quantity per Package

5

Contains DI Package

30884527021790

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK

"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