LifeShield Infusion Safety Software Suite - LifeShield CDR 17005-01

GUDID 00887709122819

Infusion Safety Management Software

ICU MEDICAL, INC.

Medical equipment clinical data interfacing software

• Primary Device ID: 00887709122819
• NIH Device Record Key: c106a31a-c4e1-445d-8ee8-c2b7d27506b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeShield Infusion Safety Software Suite - LifeShield CDR
• Version Model Number: 2.1
• Catalog Number: 17005-01
• Company DUNS: 118380146
• Company Name: ICU MEDICAL, INC.
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com
• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887709122819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223606

FDA Product Code

• PHC: Infusion safety management software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-11
• Device Publish Date: 2023-10-03

Devices Manufactured by ICU MEDICAL, INC.

• 10887709185538 - Bivona: 2026-02-23 FT26BN35NGF113N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709185606 - Bivona: 2026-02-23 FT26BN40NGF115N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709185613 - Bivona: 2026-02-23 FT26BN35NGF114N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709185620 - Bivona: 2026-02-23 FP26BN40NSF116N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709185637 - Bivona: 2026-02-23 FU26BN30NGF118N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709185651 - Bivona: 2026-02-23 SU26BN40NGF119NBivona DI: Non-Adjustable-Non-Wired-Non-Sterile
• 10887709185330 - Bivona: 2026-02-19 FT26BN35NGF089N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709185347 - Bivona: 2026-02-19 FT26BN40NGF090N Bivona DI: Non-Adjustable-Wired_Non-Sterile