Covidien - Covidien Disposable Chest Leads, V-Leads - HYGIA HEALTH SERVICES, INC.

Duns Number:177939027

Device Description: Covidien Disposable Chest Leads, V-Leads

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More Product Details

Catalog Number

-

Brand Name

Covidien

Version/Model Number

33111

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2019

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)

-

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

938624d8-b429-45c0-9414-ef86f90023fc

Public Version Date

March 19, 2021

Public Version Number

3

DI Record Publish Date

September 30, 2016

Additional Identifiers

Package DI Number

30817357020893

Quantity per Package

10

Contains DI Package

10817357020899

Package Discontinue Date

March 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Box

"HYGIA HEALTH SERVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 49
2 A medical device with a moderate to high risk that requires special controls. 178