FDA.reportPublic FDA data

Alaris

Primary DI
10885403494291
Brand
Alaris
Company
CAREFUSION 303, INC.
Model
8120
Catalog number
8120
Device description
Alaris PCA Module
Published
2021-09-29
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
K043299000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043299000MEDLEY PCA MODULE, MODEL 8120Alaris Medical Systems, Inc.2004-12-10MEA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403494291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540349429110885403494291

GMDN Terms#

Term, Definition table
TermDefinition
Patient-controlled analgesia infusion pumpA battery-powered infusion device designed to deliver intermittent bolus doses of opioid medications [e.g., Fentanyl, Demerol (meperidine), Morphine, or Hydromorphone] upon patient demand (i.e., when activated by the patient when he/she requires pain relief), or in a slow, continuous mode for regional anaesthesia. A patient-controlled analgesia (PCA) infusion pump is used to infuse drugs into an operative site, or subcutaneously for postoperative pain management. It is used for hospital/home-use and can be worn by the patient for ambulation. It will incorporate safety mechanisms to prevent the patient overdosing; some types will employ computerized ambulatory drug delivery (CADD) software.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg
Storage Environment Humidity5 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)447-7825CustCareInfusion@carefusion.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
10885403517945AlarisCAREFUSION 303, INC.MEA2023-11-20
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
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