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.

• 10887709128511 - Bivona: 2024-10-09 FT24GN35NGE078N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128528 - Bivona: 2024-10-09 FT24GN35NSE226NBivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128535 - Bivona: 2024-10-09 FT24GN25NSA003N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128542 - Bivona: 2024-10-09 FT24HN60NGF004N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128559 - Bivona: 2024-10-09 FT24HN35NGE005N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128566 - Bivona: 2024-10-09 XT24HS35NGZ006N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128573 - Bivona: 2024-10-09 AU24HS80NSC007N Bivona DI Template: Adjustable Non-Sterile
• 10887709128580 - Bivona: 2024-10-09 FT24HN55NSF008N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile