Stealth System S300 M300-5

GUDID 20857553006072

Stealth System Wearable Sensor (M300).

CARDIAC INSIGHT, INC.

Electrocardiographic ambulatory recorder
Primary Device ID20857553006072
NIH Device Record Key03f9f8ab-c7c1-4b55-98dc-a948b01f3f69
Commercial Distribution StatusIn Commercial Distribution
Brand NameStealth System S300
Version Model NumberM300-5
Catalog NumberM300-5
Company DUNS827419834
Company NameCARDIAC INSIGHT, INC.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com
Phone2065962060
Emailsupport@cardiacinsightinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100857553006078 [Unit of Use]
GS120857553006072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2017-03-29

On-Brand Devices [Stealth System S300]

00857553006092StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300)
20857553006072Stealth System Wearable Sensor (M300).

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