MedSystem III, SmartSite 28004E

GUDID 37613203011427

MedSystem III SmartSite Infusion Set

CAREFUSION 303, INC.

Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use

• Primary Device ID: 37613203011427
• NIH Device Record Key: 004dcd6c-31ed-454d-9d8b-4c63d49ab516
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSystem III, SmartSite
• Version Model Number: 28004E
• Catalog Number: 28004E
• Company DUNS: 360624720
• Company Name: CAREFUSION 303, INC.
• Device Count: 50
• 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	07613203011419 [Unit of Use]
GS1	37613203011427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K874564

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 [MedSystem III, SmartSite]

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