TeleSense 3 Lead Patient Cable 30" - 30" 3 lead ECG patient cable for use with the - SCOTTCARE CORPORATION, THE

Duns Number:808204957

Device Description: 30" 3 lead ECG patient cable for use with the TeleSenseRCM or TeleSense-E devices.

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More Product Details

Catalog Number

101826

Brand Name

TeleSense 3 Lead Patient Cable 30"

Version/Model Number

TeleSense 3 Lead Patient Cable 30"

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

K142180

Product Code Details

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Device Record Status

Public Device Record Key

5d4b53ec-c52e-4bcf-bea7-d3020915cb59

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