Alaris, VersaSafe, Signature Edition 11141556

GUDID 70885403422234

SE W/150 MC, 0.2 MF 3VS DEHP FREE

CAREFUSION 303, INC.

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

• Primary Device ID: 70885403422234
• NIH Device Record Key: 9b29e786-22d0-4d03-865f-485f8def3041
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alaris, VersaSafe, Signature Edition
• Version Model Number: 11141556
• Catalog Number: 11141556
• 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	10885403422232 [Unit of Use]
GS1	50885403422230 [Primary]
GS1	70885403422234 [Package]; Contains: 50885403422230; Package: Pallet [49 Units]; In Commercial Distribution

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: 2017-02-07

Devices Manufactured by CAREFUSION 303, INC.

• 10885403519284 - Alaris: 2024-06-03 BD Alaris PC Unit (V12.3.2)
• 10885403821011 - Alaris: 2024-05-09 Alaris SP02 Module Nellcor
• 10885403822018 - Alaris: 2024-05-09 Alaris SP02 Module Massimo
• 10885403860003 - Alaris: 2024-05-06 Alaris Auto-ID Module (v8)
• 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+)