LifeShield Infusion Safety Software Suite - LifeShield DLM

Basic Information

• Brand Name: LifeShield Infusion Safety Software Suite - LifeShield DLM
• Primary DI: 00887709122802
• Version / Model: 2.1
• Catalog Number: 17003-01
• Company Name: ICU MEDICAL, INC.
• Labeler DUNS: 118380146
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-03
• Public Version: 1
• Public Version Date: 2023-10-11
• Public Version Status: New
• Public Device Record Key: 8d624751-2ace-4b92-a14f-9983e695c4df

Device Description

Infusion Safety Management Software

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PHC	Infusion safety management software	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47903	Infusion pump medication-dosage application software	A software program intended to enable a healthcare professional to create, modify and store (manage) dosage parameters (protocols) for delivery of medication by an electronic infusion pump(s) or a syringe pump(s) which is used in a hospital/institution (e.g., IV pole mounted) or used for ambulatory purposes [also known as computerized ambulatory drug delivery (CADD)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887709122802	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K223606	000