USB Cable - ECG Module USB Cable (3 meters) - GLOBAL INSTRUMENTATION, LLC

Duns Number:147035427

Device Description: ECG Module USB Cable (3 meters)

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More Product Details

Catalog Number

007-400-0145

Brand Name

USB Cable

Version/Model Number

007-400-0145

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

-

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

DSI

Product Code Name

Detector And Alarm, Arrhythmia

Device Record Status

Public Device Record Key

acddf38e-3b25-4711-88de-96ef070bb423

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 29, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GLOBAL INSTRUMENTATION, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 49