Alaris, VersaSafe, SmartSite 42134E

GUDID 50885403274235

Alaris VersaSafe SmartSite Gravity Set

CAREFUSION 303, INC.

Intravenous administration set Intravenous administration set Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive

• Primary Device ID: 50885403274235
• NIH Device Record Key: fb58e8b1-6a75-489e-8955-e0e8b2af1c06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alaris, VersaSafe, SmartSite
• Version Model Number: 42134E
• Catalog Number: 42134E
• 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
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com
• 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
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 125 Degrees Fahrenheit
• 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	10885403274237 [Unit of Use]
GS1	50885403274235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K820278

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: 5
• Public Version Date: 2020-04-27
• Device Publish Date: 2016-10-17

Devices Manufactured by CAREFUSION 303, INC.

• 10885403519215 - BD Alaris: 2024-04-09 BD Alaris PC Unit (R V12.4.X)
• 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