FDA.reportPublic FDA data

Alaris

Primary DI
10885403517945
Brand
Alaris
Company
CAREFUSION 303, INC.
Model
8120
Device description
Alaris PCA Module (REM V12.3+)
Published
2023-11-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEAPump, infusion, pca

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEAPump, Infusion, PcaGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211218000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211218000BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc.2023-07-21FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403517945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540351794510885403517945

GMDN Terms#

Term, Definition table
TermDefinition
Bedside syringe pumpA mains electricity (AC-powered) non-ambulatory 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 to allow operation 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(844)823-5433ProductComplaints@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
10885403519451BD Alaris™ Syringe Module, Model 8110CAREFUSION 303, INC.MEA2026-10-08
10885403519468Alaris™ PCA Module, Model 8120CAREFUSION 303, INC.MEA2026-10-08
10885403533259Alaris™ PCA Module Model 8120CAREFUSION 303, INC.MEA2026-10-08
10885403533266Alaris™ PCA Module Model 8120CAREFUSION 303, INC.MEA2026-10-08
00193494001988ambIT* DISPOSABLE PLUSAvanos Medical, Inc.MEA2025-08-27
10193494001985ambIT* DISPOSABLE PLUSAvanos Medical, Inc.MEA2025-08-27
10885403516030Alaris™ PCA Module, Model 8120CAREFUSION 303, INC.MEA2023-09-18
00193494000776ambIT* Remote Bolus SwitchAvanos Medical, Inc.MEA2023-04-05
20193494000770ambIT* Remote Bolus SwitchAvanos Medical, Inc.MEA2023-04-05
00193494001292ambIT* PIB-PCA v1.5 System w/Male Filter CassAvanos Medical, Inc.MEA2022-11-04
00193494001308ambIT* PIB-PCA v1.5 System w/Spike Filter CassAvanos Medical, Inc.MEA2022-11-04
00193494001315ambIT* PIB/PCA Pump V1.5Avanos Medical, Inc.MEA2022-02-24
00193494000707ambIT* PIB-PCA PumpAvanos Medical, Inc.MEA2022-02-07
00193494000769ambIT* PIB*IL PumpAvanos Medical, Inc.MEA2022-02-07
00193494000813ambIT* PCA PumpAvanos Medical, Inc.MEA2022-02-07
00193494001216ambIT* KIDS PIB Pump-BlueAvanos Medical, Inc.MEA2022-02-07
00193494001384ambIT* PIB IL v 1.5Avanos Medical, Inc.MEA2022-02-07
00193494000387ambIT* Cassette - Filter, Male Neuraxial ConnectorAvanos Medical, Inc.MEA2022-01-17
10885403494291AlarisCAREFUSION 303, INC.MEA2021-09-29
00817170020376Nimbus II EpiDINFUTRONIX LLCMEA2020-09-02
00850000509078ambITSUMMIT MEDICAL PRODUCTS, INC.MEA2020-08-17
B101100500PXE0Manufacturing Kit CMExpress® PumpCME AMERICA LLCMEA2020-07-08
00857595005923ambIT SUMMIT MEDICAL PRODUCTS, INC.MEA2020-05-06
00850000509023ambITSUMMIT MEDICAL PRODUCTS, INC.MEA2020-04-23
00850000509030ambITSUMMIT MEDICAL PRODUCTS, INC.MEA2020-04-23
15019517154986CADDICU MEDICAL, INC.MEA2020-02-28
15019517155006CADDICU MEDICAL, INC.MEA2020-02-28
15019517197112PharmGuardICU MEDICAL, INC.MEA2020-01-27
15019517165753CADDICU MEDICAL, INC.MEA2019-12-30
15019517171969CADDICU MEDICAL, INC.MEA2019-12-30