Athena GTX Device Management Suite (ADMS) Software 395-0010-00

GUDID B3943950010000

Athena GTX Device Management Suite - Android

ATHENA GTX, INC.

Patient monitoring system central station monitor
Primary Device IDB3943950010000
NIH Device Record Key5ddaa500-4768-4766-bee9-982ca3bb6e9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAthena GTX Device Management Suite (ADMS) Software
Version Model NumberADMS Android Software
Catalog Number395-0010-00
Company DUNS048031913
Company NameATHENA GTX, INC.
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 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

Phone515-288-3360
Emailinfo@athenagtx.com
Phone515-288-3360
Emailinfo@athenagtx.com
Phone515-288-3360
Emailinfo@athenagtx.com
Phone515-288-3360
Emailinfo@athenagtx.com
Phone515-288-3360
Emailinfo@athenagtx.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB3943950010000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-20

On-Brand Devices [Athena GTX Device Management Suite (ADMS) Software]

B3943950010000Athena GTX Device Management Suite - Android
B3943950009000Athena GTX Device Management Suite - iOS
B3943900008000Athena GTX Device Management Suite - PC
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