ICU Medical, Inc.

GUDID 10610586032660

GIN for 21-4437-24, POWER PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO, 1/EA

ICU MEDICAL, INC.

Vascular port/catheter

• Primary Device ID: 10610586032660
• NIH Device Record Key: 28a16634-28a0-4986-8017-c9c5f6be8e76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICU Medical, Inc.
• Version Model Number: 21-4437-24
• Company DUNS: 118380146
• Company Name: ICU MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	10610586032660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093414

FDA Product Code

• LJT: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, 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: 1
• Public Version Date: 2026-01-13
• Device Publish Date: 2026-01-05

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
• 10887709128221: GTIN for AM3130, 1/EA
• 10887709092027: GTIN for MC330523, 1/EA
• 10887709037813: GTIN for MC33332, 1/EA
• 35019517393648: GTIN FOR 21-3463-24, 1/EA
• 35019517393624: GTIN FOR 21-3371-24, 1/EA
• 35019517393617: GTIN FOR 21-3462-24, 1/EA
• 35019517393600: GTIN FOR 21-3366-24, 1/EA
• 35019517393594: GTIN FOR 21-3461-24, 1/EA
• 35019517393587: GTIN FOR 21-3460-24, 1/EA
• 35019517393570: GTIN FOR 21-3370-24, 1/EA
• 35019517393631: GTIN FOR 21-3372-24, 1/EA
• 10887709165172: GTIN for B33985, 1/EA
• 10610586032660: GIN for 21-4437-24, POWER PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO, 1/EA
• 10887709176000: GTIN for 46117-44, 1/EA
• 10887709175997: GTIN for 46117-43, 1/EA
• 10887709175980: GTIN for 46117-42, 1/EA