FDA.reportPublic FDA data

Amplion Care Assurance

Primary DI
00850016398208
Brand
Amplion Care Assurance
Company
AMPLION CLINICAL COMMUNICATIONS, INC.
Model
D-PAS-12-1
Catalog number
D-PAS-12-1
Device description
Patient Station (PAS), Version 1.2
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
00850016398208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016398208008500163982088500163982080850016398208

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
00850016398130Amplion Care AssuranceD-CDIS-20-7D-CDIS-20-72020-04-30
00850016398147Amplion Care AssuranceD-CAS-11-1D-CAS-11-12020-04-30
00850016398154Amplion Care AssuranceD-CPS-10-1D-CPS-10-12020-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828196475GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196482GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196499GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196505GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196512GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196529GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196536GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196543GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196550GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196567GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196574GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196581GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196598GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196604GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196611GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196628GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196635GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196642GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196659GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196444GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-19
00840828196451GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-05-19
00840828196406GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-07
00840828196413GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-05-07
00840828196437GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-07
00840828196369GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-04-23
00840828196376GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-04-23
00840828196383GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-04-23
00840828196390GEN4 PLUS, DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-04-23
00840828196284GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-04-08
00840828196253GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-04-01