Level 1

GUDID 30695085002967

ICU MEDICAL, INC.

Electrical-only medical device connection cable, reusable

• Primary Device ID: 30695085002967
• NIH Device Record Key: 43aa2ca6-27bf-4236-b9fa-7d42dc8bf5c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Level 1
• Version Model Number: C400-5
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10695085002963 [Primary]
GS1	30695085002967 [Package]; Contains: 10695085002963; Package: BOX [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912280

FDA Product Code

• FLL: Thermometer, electronic, clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2025-04-16
• Device Publish Date: 2016-10-14

On-Brand Devices [Level 1]

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