ICU Medical, Inc.

GUDID 10887709128078

GTIN for B2229, 92" (234 cm) Appx 10.4 ml 15 Drop Admin Set w/5.0 Micron Filter, Inj Site, Spin Luer, 1/EA

ICU MEDICAL, INC.

Basic intravenous administration set, noninvasive

• Primary Device ID: 10887709128078
• NIH Device Record Key: 0f4b9d99-fe75-49a6-8d4e-544a7e0ad717
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICU Medical, Inc.
• Version Model Number: B2229
• 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	00887709128071 [Primary]
GS1	10887709128078 [Package]; Contains: 00887709128071; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964435

FDA Product Code

• FMG: Stopcock, i.V. Set

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: 2025-03-03
• Device Publish Date: 2025-02-21

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