Alaris, SmartSite 2300E-0500

GUDID 50885403235021

Alaris SmartSite Bag Access Device

CAREFUSION 303, INC.

Fluid transfer set, general-purpose

• Primary Device ID: 50885403235021
• NIH Device Record Key: c976b0fa-c892-47c6-a6b3-db146c27aad1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alaris, SmartSite
• Version Model Number: 2300E-0500
• Catalog Number: 2300E-0500
• Company DUNS: 360624720
• Company Name: CAREFUSION 303, INC.
• Device Count: 25
• 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
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.com
• Phone: +1(844)823-5433
• Email: customer_support@bd.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
• 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
• 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
• 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	10885403235023 [Unit of Use]
GS1	20885403235020 [Primary]
GS1	50885403235021 [Package]; Contains: 20885403235020; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970485

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: 4
• 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