SmartSite 10012143

GUDID 50885403233669

SmartSite Extension Set

CAREFUSION 303, INC.

Intravenous administration tubing extension set Intravenous administration tubing extension set

• Primary Device ID: 50885403233669
• NIH Device Record Key: eb8d358c-0499-48dd-8ef6-fe8158d8af38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartSite
• Version Model Number: 10012143
• Catalog Number: 10012143
• Company DUNS: 360624720
• Company Name: CAREFUSION 303, INC.
• Device Count: 100
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885403233661 [Unit of Use]
GS1	50885403233669 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960280

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 [SmartSite]

• 70885403238033: SmartSite Vented Vial Access Device
• 50885403237919: SS UNIVERSAL VENTED VAD-MULTIPACK (10)
• 50885403233669: SmartSite Extension Set
• 50885403234161: SmartSite 4-Way Stopcock