FDA.reportPublic FDA data

Alaris™ Guardrails™ Editor Software Kit, Model 8961

Primary DI
10885403520020
Brand
Alaris™ Guardrails™ Editor Software Kit, Model 8961
Company
CAREFUSION 303, INC.
Model
8961
Catalog number
49000984
Device description
Alaris™ Guardrails™ Editor Software Kit, Model 8961 v12.1.4
Published
2024-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PHCInfusion safety management software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHCInfusion Safety Management SoftwareGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403520020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540352002010885403520020

GMDN Terms#

Term, Definition table
TermDefinition
Infusion pump medication-dosage application softwareA software program intended to enable a healthcare professional to create, modify and store (manage) dosage parameters (protocols) for delivery of medication by an electronic infusion pump(s) or a syringe pump(s) which is used in a hospital/institution (e.g., IV pole mounted) or used for ambulatory purposes [also known as computerized ambulatory drug delivery (CADD)].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)823-5433ProductComplaints@bd.com

Regulatory Flags#

DUNS number
360624720
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403519666BD Alaris™ System Manager 9601, Software96019601ASMSW12522024-06-19
10885403510472BD Alaris™ Infusion Adapter, SoftwareNot ApplicableINFADPTSW1722022-08-12
10885403510489BD Alaris™ Calculation Services, SoftwareNot ApplicableCALCSRVSW1112022-06-09
10885403520761BD Alaris™ ETCO2 Module, Model 830083008300BDADXEN1262025-09-10
10885403516054BD Alaris™ ETCO2 Module, Model 830083008300BDADXEN1232023-09-18
10885403830013Alaris83002016-12-08
10885403830020Alaris83002021-10-08
10885403519475BD Alaris83008300SW12602025-12-23
10885403211423Alaris™ Pump Module, Model 81008100109386622025-12-19
10885403423208Alaris™ Syringe Module, Model 811081008110SIXEN8562025-12-19
10885403237867BD MaxGuardMY3003MY30032016-09-22
10885403533228BD Pyxis3232025-11-14
10885403533235BD Pyxis3242025-11-14
10885403533242Pyxis3273272025-11-14
10885403532528Pyxis Pro MedStation177-255177-2552025-10-17
10885403516023BD Alaris™ PCU Module, Model 801580158015BDCDXEN12312023-09-18
10885403515316Alaris™ PCA Module, Model 812081208120FDXEN12122023-06-20
10885403515231BD Alaris™ PCU Module, Model 801580158015BDMDXEN12132023-06-08
10885403515323BD Alaris™ Syringe Module, Model 811081108110FDXEN12122023-06-08
10885403516047BD® Alaris™ Syringe Module, Model 811081108110BDADXEN1232023-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885403519475BD AlarisCAREFUSION 303, INC.PHC2025-12-23
00887709127227LifeShield Infusion Safety Software SuiteICU Medical, Inc.PHC2025-05-23
00887709127234LifeShield Infusion Safety Software SuiteICU Medical, Inc.PHC2025-05-23
00887709127241LifeShield Infusion Safety Software SuiteICU Medical, Inc.PHC2025-05-23
00811505030450Ivenix Infusion SystemFresenius Kabi AGPHC2024-12-06
20085412676610DOSE IQ SAFETY SOFTWAREBAXTER HEALTHCARE CORPORATIONPHC2024-08-23
10885403519666BD Alaris™ System Manager 9601, SoftwareCAREFUSION 303, INC.PHC2024-06-19
00382905168017BD Intelliport SystemBECTON, DICKINSON AND COMPANYPHC2024-06-07
00382905168024BD Intelliport SystemBECTON, DICKINSON AND COMPANYPHC2024-06-07
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYPHC2024-06-07
60382905168033BD Intelliport SystemBECTON, DICKINSON AND COMPANYPHC2024-06-07
10085412676613DOSE IQ SAFETY SOFTWAREBAXTER HEALTHCARE CORPORATIONPHC2024-04-22
00887709122802LifeShield Infusion Safety Software Suite - LifeShield DLMICU MEDICAL, INC.PHC2023-10-03
00887709122819LifeShield Infusion Safety Software Suite - LifeShield CDRICU MEDICAL, INC.PHC2023-10-03
00811505030443Ivenix Infusion SystemFresenius Kabi AGPHC2023-08-07
00811505030399Ivenix Infusion SystemFresenius Kabi AGPHC2023-07-19
00811050530399Ivenix Infusion SystemFresenius Kabi AGPHC2023-04-07
00085412676616DOSE IQ SAFETY SOFTWAREBAXTER HEALTHCARE CORPORATIONPHC2022-09-22
00811505030351Ivenix Infusion SystemFresenius Kabi AGPHC2022-09-07
10885403510472BD Alaris™ Infusion Adapter, SoftwareCAREFUSION 303, INC.PHC2022-08-12
10885403510489BD Alaris™ Calculation Services, SoftwareCAREFUSION 303, INC.PHC2022-06-09
04052682044106Vigilant Software SuiteFresenius Kabi AGPHC2022-05-20
15019517225471PharmGuardICU MEDICAL, INC.PHC2021-11-16
10885403896125Alaris™ Guardrails™ Editor Software Kit, Model 8961CAREFUSION 303, INC.PHC2021-10-08
10885403897535Alaris™ System Maintenance Software Kit, Model 8975CAREFUSION 303, INC.PHC2021-10-08
10885403960123AlarisCAREFUSION 303, INC.PHC2021-10-08
00811505030177Ivenix Infusion SystemFresenius Kabi AGPHC2021-06-25
00860006582005CommonPath EnterpriseCritical AlertPHC2021-04-22
50382905167015BD IntelliportBECTON, DICKINSON AND COMPANYPHC2020-09-30
00382905167065BD IntelliportBECTON, DICKINSON AND COMPANYPHC2020-09-30