MedSystem III, SmartSite 28117E

GUDID 50885403274891

MedSystem III SmartSite Infusion Half Set

CAREFUSION 303, INC.

Electric infusion pump administration set, single-use
Primary Device ID50885403274891
NIH Device Record Key921b7824-ca56-4e34-a070-d5464121b3f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedSystem III, SmartSite
Version Model Number28117E
Catalog Number28117E
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

Operating and Storage Conditions

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
GS110885403274893 [Unit of Use]
GS150885403274891 [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 Number4
Public Version Date2020-04-27
Device Publish Date2016-09-22

On-Brand Devices [MedSystem III, SmartSite]

50885403275027MedSystem III SmartSite Infusion Set
50885403274921MedSystem III SmartSite Low Sorbing Infusion Set
50885403274914MedSystem III SmartSite Infusion Set
50885403274907MedSystem III SmartSite Infusion Set
50885403274891MedSystem III SmartSite Infusion Half Set
50885403274877MedSystem III SmartSite Blood Infusion Set
50885403274860MedSystem III SmartSite Infusion Burette Set
50885403274853MedSystem III SmartSite Infusion Set
37613203013728MedSystem III SmartSite Infusion Set
37613203011427MedSystem III SmartSite Infusion Set

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