Alaris, SmartSite C42016E-07

GUDID 50885403199187

Alaris SmartSite Gravity Set

CAREFUSION 303, INC.

Intravenous administration set Intravenous administration set Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive

• Primary Device ID: 50885403199187
• NIH Device Record Key: c8e641a9-3f64-4775-ac06-9af7e7eefc56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alaris, SmartSite
• Version Model Number: C42016E-07
• Catalog Number: C42016E-07
• Company DUNS: 360624720
• Company Name: CAREFUSION 303, INC.
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885403199189 [Unit of Use]
GS1	50885403199187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K820278

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-27
• Device Publish Date: 2016-09-22

On-Brand Devices [Alaris, SmartSite]

• 50885403422391: Alaris SmartSite Gravity Set
• 50885403422384: Alaris SmartSite Gravity Set
• 50885403422322: GEM60DP CV3SS 3WSTCK 2 1WAYVLV DEHPFREE
• 50885403422292: GRAVITY SET DUAL 10DP CKV 1SS 4WS
• 70885403422289: GRAVITY SET 10DP CKV 4SS
• 50885403422148: Alaris SmartSite Extension Set
• 50885403421981: Alaris SE Pump Smartsite Infusion Set
• 50885403283992: Alaris Pump Module SmartSite Infusion Set
• 50885403283930: Alaris Pump Module SmartSite Infusion Set
• 50885403276024: Alaris Pump Module SmartSite Burette Set
• 50885403275614: GEM V/NV 20DP MC 1SS DEHP Free
• 50885403275607: GEM V/NV MC 20DP 4SS CKV DEHP Free
• 50885403275591: GEM V/NV MC 3SS PORTS 20DP10PK DEHP Free
• 50885403275140: Alaris SE Pump SmartSite Infusion Set
• 50885403274266: Alaris SmartSite Gravity Set
• 50885403274259: Alaris SmartSite Gravity Set
• 50885403274242: Alaris SmartSite Gravity Set
• 50885403274228: Alaris SmartSite Gravity Set
• 50885403274211: Alaris SmartSite Gravity Set
• 50885403274136: Alaris Pump Module SmartSite Low Sorbing Half Set
• 50885403274129: Alaris Pump Module SmartSite Low Sorbing Burette Set
• 50885403274112: Alaris Pump Module SmartSite Infusion Set
• 50885403274013: Alaris Pump Module SmartSite Low Sorbing Infusion Set
• 50885403273986: Alaris SmartSite Extension Set
• 50885403273917: Alaris SmartSite Extension Set
• 50885403273764: Alaris SmartSite Extension Set
• 50885403248380: 113" GRAV SET 15DP CV SS 4W SCK 2 1W VLV
• 50885403245488: Alaris SmartSite Extension Set Gravity Set
• 50885403245419: Alaris Pump Module SmartSite Infusion Set
• 50885403244054: Alaris SmartSite Gravity Burette Set
• 50885403242043: Alaris SmartSite Extension Set
• 50885403241978: Alaris Pump Module SmartSite Low Sorbing Infusion Set
• 50885403240971: Alaris Pump Module SmartSite Low Sorbing Infusion Set
• 50885403240292: Alaris Smartsite Gravity Set
• 50885403239609: Alaris Smartsite Gravity Set
• 50885403239586: Alaris Pump Module SmartSite Infusion Set
• 50885403239579: Alaris SmartSite Bag Access Device
• 50885403238664: Alaris Pump Module SmartSite Infusion Set
• 50885403238046: Alaris Pump Module SmartSite Infusion Burette Set
• 50885403237902: GRAV 15DP CKV 3SS 2GNGD-4WSTPCK DEHP FRE
• 50885403235687: Alaris SmartSite Gravity Set
• 50885403235670: Alaris SmartSite Gravity Set
• 50885403235632: Alaris SmartSite Extension Set
• 50885403235625: Alaris Smartsite Extension Set
• 50885403235595: Alaris SmartSite Extension Set
• 50885403235588: Alaris Smartsite Extension Set
• 50885403235571: Alaris Smartsite Extension Set
• 50885403235564: Alaris Pump Module SmartSite Low Sorbing Infusion Set
• 50885403235533: Alaris Pump Module SmartSite Infusion Set
• 50885403235526: Alaris Pump Module SmartSite Amber Infusion Set