Lifeshield 1427229

GUDID 20887787008795

Primary PLUM MICRODRIP 150 mL Burette Set, Prepierced Additive Port, Prepierced Secondary Port, 2 Prepierced Y-Sites, Secure Lock, 114 Inch (previousl

ICU MEDICAL FLEET SERVICES, LLC

Electric infusion pump administration set, single-use

• Primary Device ID: 20887787008795
• NIH Device Record Key: 398e6727-448f-4bf1-9773-9e5dd9c11a90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lifeshield
• Version Model Number: 1427229
• Catalog Number: 1427229
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)946-7747
• Email: uscustomercare@icumed.com

Device Dimensions

• Length: 114 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887787008798 [Primary]
GS1	20887787008795 [Package]; Contains: 10887787008798; Package: case [48 Units]; In Commercial Distribution
HIBCC	M33514272290 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141789

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-31

On-Brand Devices [Lifeshield]

• 20887787008795: Primary PLUM MICRODRIP 150 mL Burette Set, Prepierced Additive Port, Prepierced Secondary Port,
• 20887787008566: Primary Microbore PLUM Set 2 CLAVE Y-Sites, Secure Lock, 98 Inch (previously Hospira product)
• 20887787005015: Microbore Extension Set, 10 Inch 0.2 Micron Filter, Prepierced Y-Site, Secure Lock (previously H
• 20887787003202: Primary PLUM Set CLAVE Secondary Port, Backcheck Valve, 2 CLAVE Y-Sites, Secure Lock, 104 Inch (