FDA.reportPublic FDA data

Alaris™ System Maintenance Software Kit, Model 8975

Primary DI
10885403897535
Brand
Alaris™ System Maintenance Software Kit, Model 8975
Company
CAREFUSION 303, INC.
Model
8975
Catalog number
49000546
Device description
Alaris™ System Maintenance Software Kit, Model 8975 v12.5.0
Published
2021-10-08
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
FRNPump, infusion
PHCInfusion safety management software

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133532000
K211218000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133532000ALARIS SYSTEM WITH GUARDRAILS SUITE MXCarefusion 303, Inc.2014-08-21FRN
K211218000BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc.2023-07-21FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403897535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540389753510885403897535

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(888)237-2762ProductComplaints@bd.com
+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
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
10885403519499Alaris™ System Maintenance Software Kit, Model 897549000973490009732026-10-08
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

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
10885403532948BD Alaris™ PCU Module, Model 8015CAREFUSION 303, INC.FRN2026-10-22
00856038001942IradimedIRADIMED CORP.FRN2026-10-08
10885403519437BD Alaris™ PCU Module, Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403519482Alaris™ Guardrails™ Editor Software Kit, Model 8961CAREFUSION 303, INC.PHC2026-10-08
10885403519499Alaris™ System Maintenance Software Kit, Model 8975CAREFUSION 303, INC.PHC2026-10-08
10885403533211BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533273BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533297BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533334BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533426BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403535215BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403542930BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
05060844770014SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770021SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770038SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770045SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770052SAFIRAMEDOVATE LIMITEDFRN2026-10-05
04046955664214B.BRAUNB. BRAUN MEDICAL INC.FRN2026-07-12
04046961034704Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
04046961034834Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
00860006582012TigerConnect Alarm ManagementCritical AlertPHC2026-05-29
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYPHC2024-06-07
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16