Amplion Care Assurance

Basic Information

• Brand Name: Amplion Care Assurance
• Primary DI: 00850016398741
• Version / Model: S-APP-240-1
• Catalog Number: S-APP-240-1
• Company Name: AMPLION CLINICAL COMMUNICATIONS, INC.
• Labeler DUNS: 626493555
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-07
• Public Version: 2
• Public Version Date: 2023-12-27
• Public Version Status: Update
• Public Device Record Key: 1e1563f6-8624-451d-a368-c5f5f8203231
• Distribution End Date: 2023-12-20

Device Description

Amplion phone application for the Android OS system used on smartphones, Version 2.4.0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
IQA	System, Environmental Control, Powered	Physical Medicine	890.3725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62165	Nurse call system	An assembly of electronic devices, integrated within a facility infrastructure and/or wireless network, designed to provide an audio/visual signal to summon help when activated in response to a patient’s need for (urgent) assistance. It typically consists of and/or interacts with user- or sensor-activated signal transmitters (e.g., patient-worn pendant, push-buttons, microphones, speakers, fall sensors, smoke alarm, door sensors), a network communicator, and alert communication devices (e.g., server computer, phone, dome lights, audible alarm). The device notifies medical professionals and caregivers and is intended for use in the healthcare facility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850016398741	GS1

Customer Contacts

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