Alaris, Signature Edition, SmartSite 10784614

GUDID 50885403422216

SE 20DP NO YS

CAREFUSION 303, INC.

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

• Primary Device ID: 50885403422216
• NIH Device Record Key: 4b87e1d1-41a3-4737-89d3-660b62d980a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alaris, Signature Edition, SmartSite
• Version Model Number: 10784614
• Catalog Number: 10784614
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885403422218 [Unit of Use]
GS1	50885403422216 [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: 2017-07-27

On-Brand Devices [Alaris, Signature Edition, SmartSite]

• 50885403422216: SE 20DP NO YS
• 50885403422193: Alaris Signature Edition SmartSite Infusion Set
• 50885403422087: Alaris SE Pump Module SmartSite Infusion Set
• 50885403422001: Alaris Signature Edition SmartSite Burette Infusion Set
• 50885403275409: Alaris SE Pump SmartSite Infusion Burette Set
• 50885403275393: Alaris SE Pump SmartSite Blood Infusion Set
• 50885403275386: Alaris SE Pump SmartSite Blood Infusion Set
• 50885403275362: Alaris SE Pump SmartSite Infusion Set
• 50885403275355: Alaris SE Pump SmartSite Infusion Set
• 50885403275331: Alaris SE Pump SmartSite Infusion Set
• 50885403275317: Alaris SE Pump SmartSite Infusion Set
• 50885403275300: Alaris SE Pump SmartSite Burette Infusion Set
• 50885403275287: Alaris SE Pump SmartSite Infusion Set
• 50885403275270: Alaris SE Pump SmartSite Infusion Set
• 50885403275232: Alaris SE Pump SmartSite Infusion Set
• 50885403275218: Alaris SE Pump SmartSite Infusion Set
• 50885403275201: Alaris SE Pump SmartSite Infusion Set
• 50885403275195: Alaris SE Pump SmartSite Infusion Set
• 50885403275133: Alaris SE Pump SmartSite Infusion Set
• 50885403275126: Alaris SE Pump SmartSite Infusion Set
• 50885403275102: Alaris SE Pump SmartSite Infusion Set
• 37613203010550: Alaris SE Pump SmartSite Infusion Set
• 37613203010321: Alaris SE Pump SmartSite Infusion Set
• 37613203010284: Alaris SE Pump SmartSite Infusion Set
• 37613203010222: Alaris SE Pump SmartSite Burette Infusion Set
• 37613203010147: Alaris SE Pump SmartSite Burette Infusion Set
• 37613203010123: Alaris SE Pump SmartSite Burette Infusion Set
• 37613203010000: Alaris SE Pump SmartSite Infusion Set
• 37613203009882: Alaris Signature Edition SmartSite Infusion Half Set
• 37613203009745: Alaris SE Pump SmartSite Blood Set
• 37613203009349: Alaris SE Pump SmartSite Burette Infusion Set