ICU Medical, INC.

GUDID M335400011

Plum Solo 1.0 Infusion System

ICU MEDICAL, INC.

Bedside infusion pump, single-channel

• Primary Device ID: M335400011
• NIH Device Record Key: 55de89f5-0510-441d-a7db-c2830f7093d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICU Medical, INC.
• Version Model Number: 400010401
• Company DUNS: 118380146
• Company Name: ICU MEDICAL, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M335400011 [Primary]

FDA Product Code

• FRN: Pump, Infusion

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: 2025-05-06
• Device Publish Date: 2025-04-28

On-Brand Devices [ICU Medical, INC.]

• 10887709128078: GTIN for B2229, 92" (234 cm) Appx 10.4 ml 15 Drop Admin Set w/5.0 Micron Filter, Inj Site, Spin
• 10887709127361: GTIN for MC330716, 1/EA
• 10887709127354: GTIN for B33984, 1/EA
• 10887709128092: GTIN for 46117-40, 1/EA
• 10887709128061: GTIN for CH-19, 1/EA
• 10887709128009: GTIN for PA01-XS, 46" (117 cm) Single Lead Transfer Set w/Clamp, Luer Lock, 1/EA
• M335400031: Plum Duo 1.2 Infusion System
• M335400011: Plum Solo 1.0 Infusion System