Amplion Care Assurance F-PAS-63d6c96-1

GUDID 00850016398499

Bootloader Firmware for Patient Station (PAS)

AMPLION CLINICAL COMMUNICATIONS, INC.

Nurse call system
Primary Device ID00850016398499
NIH Device Record Keyf601b459-7a37-49aa-95b5-1eeb5a65e3e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmplion Care Assurance
Version Model NumberF-PAS-63d6c96-1
Catalog NumberF-PAS-63d6c96-1
Company DUNS626493555
Company NameAMPLION CLINICAL COMMUNICATIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com
Phone615-843-9000
Emailsupport@amplioncare.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850016398499 [Primary]

FDA Product Code

IQASystem, Environmental Control, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-08
Device Publish Date2020-04-30

On-Brand Devices [Amplion Care Assurance]

00850016398628Bootloader Firmware for version 1.2 of Clinical Device Input Station (CDIS)
00850016398611Firmware for version 1.2 of Clinical Device Input Station (CDIS), Version 326C
00850016398604Firmware for version 1.2 of Clinical Device Input Station (CDIS), Version 126E
00850016398598Bootloader Firmware for version 2.0 of Clinical Device Input Station (CDIS)
00850016398581Firmware for version 2.0 of Clinical Device Input Station (CDIS), Version D672
00850016398574Firmware for version 2.0 of Clinical Device Input Station (CDIS), Version A225
00850016398567Firmware for version 2.0 of Clinical Device Input Station (CDIS), Version 36D5
00850016398550Firmware for Toilet Station (TS), Version B4AF
00850016398543Firmware for Shower Station (SHS), Version 3356
00850016398536Bootloader Firmware for Bed Input Station (BIS)
00850016398529Firmware for Bed Input Station (BIS), Version 9551
00850016398512Bootloader Firmware for Smart Room Controller (SRC) and Zone Controller (ZC)
00850016398505Firmware for Smart Room Controller (SRC) and Zone Controller (ZC), Version 1749
00850016398499Bootloader Firmware for Patient Station (PAS)
00850016398482Firmware for Patient Station (PAS), Version 5730
00850016398475Bootloader Firmware for Code Blue Station (CBS), Code Pink Station (CPS), Shower Station (SHS),
00850016398468Firmware for Emergency Station (ES), Version C80A
00850016398451Firmware for Duty Station (DS), Version F886
00850016398444Firmware for Duty Station (DS), Version 81B5
00850016398437Bootloader Firmware for Smart Light (SL) and Zone Light (ZL)
00850016398420Firmware for Smart Light (SL) and Zone Light (ZL), Version 4A86
00850016398413Firmware for Code Pink Station (CPS), Version B1BF
00850016398406Firmware for Care Assurance Station (CAS), Version 288A
00850016398390Software for Smart Room Controller, Version 1.8.7
00850016398383Software for Nurse Station Console, Version 2.2.0.0
00850016398376Software for Nurse Call Controller and Nurse Call Web Directory, Version 1.8.7, with additional
00850016398369Software for Nurse Call Controller & Nurse Call Web Directory, Version 1.8.7
00850016398352Software for Messaging Controller, Version 1.8.7
00850016398345Software for Code Blue Annunciator, Version 1.8.7
00850016398338Amplion phone application for the Android OS system used on smartphones, Version 2.3.8
00850016398321Zone Light (ZL), Version 1.1
00850016398314Zone Controller (ZC), Version 1.2
00850016398307Toilet Station (TS), Version 1.3
00850016398291Toilet Station (TS), Version 1.2
00850016398284Smart Room Controller (No Audio) (SRCNA), Version 1.2, with No Audio
00850016398277Smart Room Controller (SRC), Version 1.4, with Audio
00850016398260Smart Room Controller (SRC), Version 1.3R, with Audio
00850016398253Smart Room Controller (SRC), Version 1.2, with Audio
00850016398246Smart Light (SL), Version 1.1
00850016398239Shower Station (SHS), Version 1.1
00850016398222Patient Station (No Audio) (PASNA), Version 1.3, with No Audio
00850016398215Patient Station (PAS), Version 1.3
00850016398208Patient Station (PAS), Version 1.2
00850016398192Mushroom Nurse Call Button (MNC) with cable harness
00850016398185Emergency Station (ES), Version 1.0
00850016398178Duty Station (DS), Version 1.1
00850016398161Daughter Board (DB), Version 1.0 - Configuration 1 includes a keypad with the following features
00850016398154Code Pink Station (CPS), Version 1.0
00850016398147Care Assurance Station (CAS), Version 1.1
00850016398130Clinical Device Input Station (CDIS), Version 2.0 - Configuration 7 includes a keypad with the f

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.