Athena GTX Device Management Suite (ADMS) Software

Basic Information

• Brand Name: Athena GTX Device Management Suite (ADMS) Software
• Primary DI: B3943950010000
• Version / Model: ADMS Android Software
• Catalog Number: 395-0010-00
• Company Name: ATHENA GTX, INC.
• Labeler DUNS: 048031913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-20
• Public Version: 3
• Public Version Date: 2020-05-19
• Public Version Status: Update
• Public Device Record Key: 5ddaa500-4768-4766-bee9-982ca3bb6e9c

Device Description

Athena GTX Device Management Suite - Android

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2
MLD	Monitor, St Segment With Alarm	Cardiovascular	870.1025	2
DQA	Oximeter	Cardiovascular	870.2700	2
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	870.1025	2
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	870.2300	2
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	870.1025	2
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38470	Centralized patient monitor	A mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B3943950010000	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173203	000