FDA.reportPublic FDA data

Alaris

Primary DI
10885403811036
Brand
Alaris
Company
CAREFUSION 303, INC.
Model
8110
Device description
Alaris Syringe Module
Published
2021-11-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRNPump, infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072105000ALARIS SYSTEM WITH MMS, MODEL 8XXXCardinal Health 303,Inc.2007-12-28FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403811036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540381103610885403811036

GMDN Terms#

Term, Definition table
TermDefinition
Syringe pumpA mains electricity (AC-powered) device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution (e.g., 0.1 ml/hr), it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It can also be used to administer epidural analgesia. It will typically have internal batteries that allow the device to operate for a short period of time when no line power is available (e.g., during transport or a power outage).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal101 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)237-2762ProductComplaints@bd.com

Regulatory Flags#

DUNS number
360624720
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10885403533242Pyxis3273272025-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856038001942IradimedIRADIMED CORP.FRN2026-10-08
10885403519437BD Alaris™ PCU Module, Model 8015CAREFUSION 303, INC.FRN2026-10-08
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
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTDFRN2023-09-05
30815112020034Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
30815112020614Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTDFRN2022-05-15
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-11
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29
15019517177367PharmGuardICU MEDICAL, INC.FRN2020-03-20
15019517177374PharmGuardICU MEDICAL, INC.FRN2020-03-20