A.C.T. (American Cardiac Telemetry) RX93030-008

GUDID 00851074007347

ECG Holter Recorder

DATRIX LLC

Telemetric electrocardiographic ambulatory recorder
Primary Device ID00851074007347
NIH Device Record Keye61a0b41-2e2e-4431-9886-4a106f7fdc2c
Commercial Distribution StatusIn Commercial Distribution
Brand NameA.C.T. (American Cardiac Telemetry)
Version Model NumberSirona
Catalog NumberRX93030-008
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

Phone760 480-8874
EmailTBREWER@DATRIXMED.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100851074007347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2018-03-05

Devices Manufactured by DATRIX LLC

00851074007385 - CardioLabs2019-11-08 ECG Recorder (Event)
00851074007392 - TLC Diagnostics2019-11-08 ECG recorder
00851074007361 - Datrix2019-11-08 ECG Recorder
00851074007002 - Sirona2019-11-08 ECG Recorder
00851074007019 - VX3+2019-11-08 Holter Recorder
00851074007026 - VX3+2019-11-08 Holter Recorder
00851074007033 - BodyGuardian2019-11-08 Holter Recorder
00851074007040 - CardioHolter2019-11-08 Holter Recorder

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