FDA.reportPublic FDA data

ARIAL

Primary DI
00840948102769
Brand
ARIAL
Company
Securitas Healthcare LLC
Model
54305
Catalog number
54305
Device description
Arial 11 Software
Published
2022-12-22
Public version status
Update
Distribution status
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
00840948102769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840948102769008409481027698409481027690840948102769

GMDN Terms#

Term, Definition table
TermDefinition
Fixed call buttonA battery-powered electronic switch intended to initiate an alert signal for help when manually activated by a user in response to a need of assistance (e.g., general care, low insulin levels). It typically consists of a bedside, wall-affixed, push-button or pull-cord, wireless radio-frequency transmitter which activates a nurse call or home alert system communication device (e.g., central server, phone, pager) to notify a medical professional, caregiver, neighbour, or emergency medical services (EMS) that assistance is needed. It is intended to be used in the home and healthcare facility.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)380-8883Support_all@sbdinc.com

Regulatory Flags#

DUNS number
079758354
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840948103414Securitas Healthcare0850-3942026-01-13
00840948103421Securitas Healthcare0850-3952026-01-13
00840948103438Securitas Healthcare543062026-01-13
00840948103445Securitas Healthcare0850-4032026-01-13
00840948103452Securitas Healthcare0850-4042026-01-13
00840948103469Securitas Healthcare545102026-01-13
00840948103339Securitas Healthcare0707-9452025-09-26
00840948103346Securitas Healthcare242012025-09-26
00840948103285Securitas Healthcare75000750002024-10-29
00840948103292Securitas Healthcare75001750012024-10-29
00840948103308Securitas Healthcare75002750022024-10-29
00840948103315Securitas Healthcare74010740102024-10-29
00840948103322Securitas Healthcare74011740112024-10-29
00840948101144ARIAL59362593622024-06-13
00840948101915ARIAL2560-593612560-593612024-06-13
00840948101922ARIAL2560-593622560-593622024-06-13
00840948102981ARIALTAG-P1000-WTAG-P1000-W2024-06-13
00840948102998ARIAL52116521162024-06-13
00840948103001ARIAL54745547452024-06-13
00840948103018ARIAL0850-1730850-1732024-06-13

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