ICU Medical MedNet 160379201

GUDID 10887787009115

Mednet Software

ICU MEDICAL FLEET SERVICES, LLC

Infusion pump medication-dosage application software

• Primary Device ID: 10887787009115
• NIH Device Record Key: 8dfdcc78-9136-4f2c-bafb-d2aac5f4f9d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICU Medical MedNet
• Version Model Number: 6.30.01
• Catalog Number: 160379201
• Company DUNS: 830767898
• Company Name: ICU MEDICAL FLEET SERVICES, LLC
• 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)241-4002
• Email: TSC.Support@icumed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887787009115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141102

FDA Product Code

• PHC: Infusion safety management software

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-22
• Device Publish Date: 2018-03-27

Devices Manufactured by ICU MEDICAL FLEET SERVICES, LLC

• 00840619085421 - ICU Medical: 2021-09-03 Optical Module, Black, OPMOD
• 10887787009115 - ICU Medical MedNet: 2020-01-22Mednet Software
• 10887787009115 - ICU Medical MedNet: 2020-01-22 Mednet Software
• 20887787003233 - Plum: 2019-12-11 Primary PLUM Set 0.2 Micron Filter, CLAVE Secondary Port, CLAVE Y-Site, Secure Lock, 112 Inch (previously Hospira product)
• 20887787003431 - Plum: 2019-12-11 Primary PLUM MICRODRIP Set CLAVE Secondary Port, Backcheck Valve, CLAVE Y-Site, Secure Lock, 104 Inch (previously Hospira produc
• 20887787005015 - Lifeshield: 2019-12-11 Microbore Extension Set, 10 Inch 0.2 Micron Filter, Prepierced Y-Site, Secure Lock (previously Hospira product)
• 20887787006715 - TUR System: 2019-12-11 LATEX-FREE T-U-R SYSTEM WITH FLOW-POUCH RESERVOIR-2000 mL For Transurethral Resection Procedures For Use With Flexible Container
• 20887787006722 - TUR Set: 2019-12-11 LATEX-FREE T-U-R Y-Set Nonvented Set for Transurethral Resection Procedures 96 inch (244 cm) For Flexible Irrigation Container S
• 20887787007248 - Irrigation Set: 2019-12-11 LATEX-FREE 4-LEAD T-U-R IRRIGATION SET Nonvented Set for Transurethral Resection Procedures 85 inch (216 cm) (previously Hospira