ICU Medical, Inc.

GUDID 10887709128061

GTIN for CH-19, 1/EA

ICU MEDICAL, INC.

Fluid transfer set, general-purpose

• Primary Device ID: 10887709128061
• NIH Device Record Key: d2594f11-80e7-45ab-9a54-06efe1d36dc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICU Medical, Inc.
• Version Model Number: CH-19
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887709128064 [Primary]
GS1	10887709128061 [Package]; Contains: 00887709128064; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173477

FDA Product Code

• ONB: Closed antineoplastic and hazardous drug reconstitution and transfer system

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-05
• Device Publish Date: 2025-04-25

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