Alaris, SmartSite, VersaSafe 10011087

GUDID 50885403233591

Alaris SmartSite VersaSafe Gravity Burette Set

CAREFUSION 303, INC.

Burette intravenous administration set 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.

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• 10885403517921 - BD Alaris: 2023-11-28 BD Alaris PC Unit (REM V12.3+)
• 10885403517938 - BD Alaris: 2023-11-28 BD Alaris Syringe Module (REM V12.3+)
• 10885403517945 - Alaris: 2023-11-28 Alaris PCA Module (REM V12.3+)
• 10885403517723 - BD Alaris: 2023-11-07 BD Alaris Pump Module (R V12.1.2+)
• 10885403517730 - Alaris: 2023-11-07 Alaris Auto-ID Module (R V8)
• 10885403517167 - BD Pyxis: 2023-10-09 BD Pyxis MedBank Tower
• 10885403517174 - BD Pyxis: 2023-10-09 BD Pyxis MedBank Tower Auxiliary