NA - IVY BIOMEDICAL ECG CABLES - Conmed Corporation

Duns Number:071595540

Device Description: IVY BIOMEDICAL ECG CABLES

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More Product Details

Catalog Number

590384

Brand Name

NA

Version/Model Number

590384

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 06, 2022

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

-

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

d851192c-45ee-482e-b17f-e85f04aea540

Public Version Date

June 07, 2022

Public Version Number

3

DI Record Publish Date

October 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CONMED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1412
2 A medical device with a moderate to high risk that requires special controls. 2261
3 A medical device with high risk that requires premarket approval 95