Patient Cable - Patient Cable 3L IEC - GLOBAL INSTRUMENTATION, LLC

Duns Number:147035427

Device Description: Patient Cable 3L IEC

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More Product Details

Catalog Number

6000-CBL3I

Brand Name

Patient Cable

Version/Model Number

007-400-0142

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)

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

DSI

Product Code Name

Detector And Alarm, Arrhythmia

Device Record Status

Public Device Record Key

8c4cbcfe-feae-4681-a347-a3841739ba90

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