Cardiostaff RX22711-003

GUDID 00851074007170

Sirona Android App

DATRIX LLC

Telemetric electrocardiographic ambulatory recorder
Primary Device ID00851074007170
NIH Device Record Keya89574dc-b5d3-43c4-88c7-834c988fdf39
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardiostaff
Version Model NumberSirona
Catalog NumberRX22711-003
Company DUNS080555401
Company NameDATRIX LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-636-9770
Emailudi@intricon.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851074007170 [Primary]

FDA Product Code

MWJElectrocardiograph,Ambulatory(Without Analysis)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-08
Device Publish Date2017-02-21

On-Brand Devices [Cardiostaff]

00851074007194Sirona PC App
00851074007170Sirona Android App

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