Alaris, SmartSite, VersaSafe 10011087

GUDID 50885403233591

Alaris SmartSite VersaSafe Gravity Burette Set

CAREFUSION 303, INC.

Burette intravenous administration set

• Primary Device ID: 50885403233591
• NIH Device Record Key: dcf7ffb9-eaf7-4378-8d91-e9b813252a3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alaris, SmartSite, VersaSafe
• Version Model Number: 10011087
• Catalog Number: 10011087
• Company DUNS: 360624720
• Company Name: CAREFUSION 303, INC.
• Device Count: 10
• 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	10885403233593 [Unit of Use]
GS1	50885403233591 [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

Devices Manufactured by CAREFUSION 303, INC.

• 10885403519475 - BD Alaris: 2025-12-31 BD Alaris™ ETC02 Module, Model 8300, Software v12.6.0
• 10885403211423 - Alaris™ Pump Module, Model 8100: 2025-12-29 Alaris™ Pump Module, Model 8100 v8.5.29.0
• 10885403423208 - Alaris™ Syringe Module, Model 8110: 2025-12-29 Alaris™ Syringe Module, Model 8110 v8.5.6 R
• 10885403533235 - BD Pyxis: 2025-11-24 BD Pyxis MedStation ES (Auxiliary)
• 10885403533242 - Pyxis: 2025-11-24 Pyxis Anesthesia System ES
• 10885403520761 - BD Alaris™ ETCO2 Module, Model 8300: 2025-09-18 BD Alaris™ ETCO2 Module, Model 8300 v12.6
• 10885403521836 - Pyxis Pro MedStation: 2025-08-11 Pyxis Pro MedStation Dispensing System cabinet, table and tray, anesthesia
• 10885403521966 - Pyxis Pro MedStation: 2025-08-11 Pyxis Pro MedStation Dispensing System cabinet, table and tray, anesthesia