Chroma2 7 Lead Patient Cable - 5 lead ECG patient cable to be used with the - SCOTTCARE CORPORATION, THE

Duns Number:808204957

Device Description: 5 lead ECG patient cable to be used with the Chroma2 device.

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More Product Details

Catalog Number

101928

Brand Name

Chroma2 7 Lead Patient Cable

Version/Model Number

Chroma2 7 Lead Patient Cable

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

K083382

Product Code Details

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Device Record Status

Public Device Record Key

fcc2156f-782f-4c70-ae64-6a8d22703152

Public Version Date

March 10, 2021

Public Version Number

5

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCOTTCARE CORPORATION, THE" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 32