FDA.reportPublic FDA data

Alaris™ System Maintenance Software Kit, Model 8975

Primary DI
10885403519499
Brand
Alaris™ System Maintenance Software Kit, Model 8975
Company
CAREFUSION 303, INC.
Model
49000973
Catalog number
49000973
Device description
Alaris™ System Maintenance Software Kit, Model 8975 v12.6
Published
2026-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10885403519499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540351949910885403519499

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)].

Contacts#

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

Regulatory Flags#

DUNS number
360624720
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403532948BD Alaris™ PCU Module, Model 801580158015SW12622026-10-22
10885403519482Alaris™ Guardrails™ Editor Software Kit, Model 896149000975490009752026-10-08
10885403519437BD Alaris™ PCU Module, Model 801580158015SW12612026-10-08
10885403519451BD Alaris™ Syringe Module, Model 811081108110SW12612026-10-08
10885403519468Alaris™ PCA Module, Model 812081208120SW12612026-10-08
10885403531521BD Alaris™ ETCO2 Module Model 830083008300BDADSEN1262026-10-08
10885403533211BD Alaris™ PCU Model 801580158015BDDDXEN12612026-10-08
10885403533259Alaris™ PCA Module Model 812081208120BDXEN12612026-10-08
10885403533266Alaris™ PCA Module Model 812081208120BDSEN12612026-10-08
10885403533273BD Alaris™ Syringe Module Model 811081108110BDADSEN12612026-10-08
10885403533297BD Alaris™ PCU Model 801580158015BDDDSEN12612026-10-08
10885403533334BD Alaris™ Syringe Module Model 811081108110BDADXEN12612026-10-08
10885403533426BD Alaris™ Pump Module, Model 810081008100BDCDXEN12612026-10-08
10885403535215BD Alaris™ Pump Module, Model 810081008100SW12612026-10-08
10885403542930BD Alaris™ Pump Module, Model 810081008100BDCDSEN12612026-10-08
10885403512629Pyxis3033032022-11-22
10885403477829Pyxis3383382018-10-15
10885403533228BD Pyxis3233232025-11-14
10885403533235BD Pyxis3243242025-11-14
10885403533242Pyxis3273272025-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709146966LifeShield Infusion Safety Software Suite - DFMICU Medical, Inc.PHC2026-10-23
10887709146973LifeShield Infusion Safety Software Suite - DLMICU Medical, Inc.PHC2026-10-23
10887709146980LifeShield Infusion Safety Software Suite - CDRICU Medical, Inc.PHC2026-10-23
10887709155050LifeShield Infusion Safety Software SuiteICU Medical, Inc.PHC2026-10-23
10885403519482Alaris™ Guardrails™ Editor Software Kit, Model 8961CAREFUSION 303, INC.PHC2026-10-08
00860006582012TigerConnect Alarm ManagementCritical AlertPHC2026-05-29
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
10885403520020Alaris™ Guardrails™ Editor Software Kit, Model 8961CAREFUSION 303, INC.PHC2024-08-02
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