FDA.reportPublic FDA data

Amplion Care Assurance

Primary DI
00850016398130
Brand
Amplion Care Assurance
Company
AMPLION CLINICAL COMMUNICATIONS, INC.
Model
D-CDIS-20-7
Catalog number
D-CDIS-20-7
Device description
Clinical Device Input Station (CDIS), Version 2.0 - Configuration 7 includes a keypad with the following features: BiPap (brown), Pad (yellow), Pulse Ox (blue)
Published
2020-04-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQASystem, Environmental Control, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQASystem, Environmental Control, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850016398130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016398130008500163981308500163981300850016398130

GMDN Terms#

Term, Definition table
TermDefinition
Nurse call systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
615-843-9000support@amplioncare.com

Regulatory Flags#

DUNS number
626493555
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850016398741Amplion Care AssuranceS-APP-240-1S-APP-240-12021-05-07
00850016398758Amplion Care AssuranceS-CBA-188-1S-CBA-188-12021-05-07
00850016398765Amplion Care AssuranceS-MGC-187-2S-MGC-187-22021-05-07
00850016398772Amplion Care AssuranceS-NSC-241-1S-NSC-241-12021-05-07
00850016398000Amplion Care AssuranceD-BIS-13-1D-BIS-13-12020-04-30
00850016398017Amplion Care AssuranceD-ADD-X-1D-ADD-X-12020-04-30
00850016398024Amplion Care AssuranceD-ADD-X-2D-ADD-X-22020-04-30
00850016398031Amplion Care AssuranceD-CDIS-12-1D-CDIS-12-12020-04-30
00850016398048Amplion Care AssuranceD-CDIS-12-2D-CDIS-12-22020-04-30
00850016398055Amplion Care AssuranceD-CDIS-12-3D-CDIS-12-32020-04-30
00850016398062Amplion Care AssuranceD-CDIS-12-4D-CDIS-12-42020-04-30
00850016398079Amplion Care AssuranceD-CDIS-20-1D-CDIS-20-12020-04-30
00850016398086Amplion Care AssuranceD-CDIS-20-2D-CDIS-20-22020-04-30
00850016398093Amplion Care AssuranceD-CDIS-20-3D-CDIS-20-32020-04-30
00850016398109Amplion Care AssuranceD-CDIS-20-4D-CDIS-20-42020-04-30
00850016398116Amplion Care AssuranceD-CDIS-20-5D-CDIS-20-52020-04-30
00850016398123Amplion Care AssuranceD-CDIS-20-6D-CDIS-20-62020-04-30
00850016398147Amplion Care AssuranceD-CAS-11-1D-CAS-11-12020-04-30
00850016398154Amplion Care AssuranceD-CPS-10-1D-CPS-10-12020-04-30
00850016398161Amplion Care AssuranceD-DB-10-1D-DB-10-12020-04-30

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00812664025134TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664025141TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
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