NA - ECG LEADWIRE SET, 4-LEAD, SNAP, AHA, 74cm/29in - GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Duns Number:006580799

Device Description: ECG LEADWIRE SET, 4-LEAD, SNAP, AHA, 74cm/29in

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

2066468-001

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

ab4d615a-ebe5-480c-af03-bd7c07d72d10

Public Version Date

March 18, 2021

Public Version Number

2

DI Record Publish Date

April 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 516