Level 1

GUDID 15019517100310

ICU MEDICAL, INC.

Frame/rail/pole device holder

• Primary Device ID: 15019517100310
• NIH Device Record Key: 45c63590-cbc0-4408-8f89-09d7b9029af8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Level 1
• Version Model Number: L1-CLAMP
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15019517100310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181699

FDA Product Code

• DWJ: System, thermal regulating

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-04-23
• Device Publish Date: 2019-08-09

On-Brand Devices [Level 1]

• 30695085002967: C400-5
• 15019517177893: L1-PWR-B-5
• 15019517100310: L1-CLAMP