Alaris, SmartSite

Primary DI
50885403234635
Brand
Alaris, SmartSite
Company
CAREFUSION 303, INC.
Model
11059727
Catalog number
11059727
Device description
Alaris SmartSite Gravity Set
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931173000PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CHImed Corp.1994-04-15FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403234635PrimaryGS10
10885403234637Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540323463550885403234635
1088540323463710885403234637

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration setA collection of noninvasive devices designed to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, clamps; the bag/bottle may be included. It does not include devices intended for invasive use nor a heat exchanger. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Fahrenheit125 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-7128CustCareInfusion@carefusion.com

Regulatory Flags#

DUNS number
360624720
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403519666BD Alaris™ System Manager 9601, Software96019601ASMSW12522024-06-19
10885403510472BD Alaris™ Infusion Adapter, SoftwareNot ApplicableINFADPTSW1722022-08-12
10885403510489BD Alaris™ Calculation Services, SoftwareNot ApplicableCALCSRVSW1112022-06-09
10885403520761BD Alaris™ ETCO2 Module, Model 830083008300BDADXEN1262025-09-10
10885403516054BD Alaris™ ETCO2 Module, Model 830083008300BDADXEN1232023-09-18
10885403830013Alaris83002016-12-08
10885403830020Alaris83002021-10-08
10885403519475BD Alaris83008300SW12602025-12-23
10885403211423Alaris™ Pump Module, Model 81008100109386622025-12-19
10885403423208Alaris™ Syringe Module, Model 811081008110SIXEN8562025-12-19
10885403237867BD MaxGuardMY3003MY30032016-09-22
10885403533228BD Pyxis3232025-11-14
10885403533235BD Pyxis3242025-11-14
10885403533242Pyxis3273272025-11-14
10885403532528Pyxis Pro MedStation177-255177-2552025-10-17
10885403516023BD Alaris™ PCU Module, Model 801580158015BDCDXEN12312023-09-18
10885403515316Alaris™ PCA Module, Model 812081208120FDXEN12122023-06-20
10885403515231BD Alaris™ PCU Module, Model 801580158015BDMDXEN12132023-06-08
10885403515323BD Alaris™ Syringe Module, Model 811081108110FDXEN12122023-06-08
10885403516047BD® Alaris™ Syringe Module, Model 811081108110BDADXEN1232023-09-12

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