Stealth System S300 C300/D300

GUDID 00857553006092

StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300).

CARDIAC INSIGHT, INC.

Electrocardiographic ambulatory recorder
Primary Device ID00857553006092
NIH Device Record Keya600072b-d9ba-402c-b6bb-30043f9aa20b
Commercial Distribution StatusIn Commercial Distribution
Brand NameStealth System S300
Version Model NumberC300/D300
Catalog NumberC300/D300
Company DUNS827419834
Company NameCARDIAC INSIGHT, INC.
Device Count1
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100857553006061 [Direct Marking]
GS100857553006092 [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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