Alaris, VersaSafe, SmartSite 42134E

GUDID 50885403274235

Alaris VersaSafe SmartSite Gravity Set

CAREFUSION 303, INC.

Intravenous administration set
Primary Device ID50885403274235
NIH Device Record Keyfb58e8b1-6a75-489e-8955-e0e8b2af1c06
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlaris, VersaSafe, SmartSite
Version Model Number42134E
Catalog Number42134E
Company DUNS360624720
Company NameCAREFUSION 303, INC.
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com
Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com
Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com
Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com
Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com
Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com
Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com
Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com
Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com
Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com
Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com
Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com
Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com
Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com
Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com
Phone+1(800)854-7128
EmailCustCareInfusion@carefusion.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 125 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110885403274237 [Unit of Use]
GS150885403274235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPASet, administration, intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-04-27
Device Publish Date2016-10-17

Devices Manufactured by CAREFUSION 303, INC.

10885403516047 - BD Alaris2024-08-19 BD Alaris Syringe Module (R V12.3+)
10885403520020 - Alaris2024-08-12 Alaris Guardrails Editor 12.1.4
10885403519666 - Alaris2024-07-09 Alaris Systems Manager v12.5.2
10885403519284 - Alaris2024-06-03 BD Alaris PC Unit (V12.3.2)
10885403821011 - Alaris2024-05-09 Alaris SP02 Module Nellcor
10885403822018 - Alaris2024-05-09 Alaris SP02 Module Massimo
10885403860003 - Alaris2024-05-06 Alaris Auto-ID Module (v8)
10885403519215 - BD Alaris2024-04-09 BD Alaris PC Unit (R V12.4.X)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.