FDA.reportPublic FDA data

Alaris

Primary DI
10885403812002
Brand
Alaris
Company
CAREFUSION 303, INC.
Model
8120
Device description
Alaris PCA Module V8
Published
2016-12-08
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
10885403812002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540381200210885403812002

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(888)812-3266ProductComplaints@bd.com
+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
10885403477829Pyxis3383382018-10-15
10885403533228BD Pyxis3233232025-11-14
10885403533235BD Pyxis3243242025-11-14
10885403533242Pyxis3273272025-11-14
10885403521836Pyxis Pro MedStation177-216177-2162025-08-01
10885403521966Pyxis Pro MedStationSW-MS-ES-PRO-V48SW-MS-ES-PRO-V482025-08-01
10885403521935Pyxis MedStationSW-MS-ES-V48SW-MS-ES-V482025-07-23
10885403517822Pyxis Pro MedStation1149-001149-002025-06-05
10885403517839Pyxis Pro MedStation1152-001152-002025-06-05
10885403521300Pyxis Pro MedStation1155-001155-002025-06-05
10885403518348BD Pyxis™SW-SVR-ES-551115-002024-12-06
10885403520327BD Pyxis™SW-MS-ES-V47SW-MS-ES-V472024-12-06
10885403520341BD Pyxis™SW-SVR-ES-57SW-SVR-ES-572024-12-06
10885403517167BD Pyxis1145-001145-002023-09-29
10885403517174BD Pyxis1146-001146-002023-09-29
10885403517181BD Pyxis1147-001147-002023-09-29
10885403517198BD Pyxis1148-001148-002023-09-29
10885403513749BD PyxisSW-MS-4000-V7SW-MS-4000-V72022-12-02
10885403513756BD PyxisSW-MS-ES-V4SW-MS-ES-V42022-12-02
10885403513770BD PyxisSW-PAS-ES-V2SW-PAS-ES-V22022-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10610586026669CADDICU MEDICAL, INC.MEA2019-12-05
10610586031212CADDICU MEDICAL, INC.MEA2019-12-05
10610586031861CADDICU MEDICAL, INC.MEA2019-12-05