Alaris, Signature Edition, SmartSite 72104KE

GUDID 50885403275300

Alaris SE Pump SmartSite Burette Infusion Set

CAREFUSION 303, INC.

Electric infusion pump administration set, single-use

• Primary Device ID: 50885403275300
• NIH Device Record Key: dd86d28d-cf46-49df-b756-f37353ad0068
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alaris, Signature Edition, SmartSite
• Version Model Number: 72104KE
• Catalog Number: 72104KE
• 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

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	10885403275302 [Unit of Use]
GS1	50885403275300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931550

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

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