Jelco

GUDID 30351688044987

ICU MEDICAL, INC.

Needle guard

• Primary Device ID: 30351688044987
• NIH Device Record Key: 742f22e8-db7e-4074-bf13-f7207426b3f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jelco
• Version Model Number: 4244
• Company DUNS: 118380146
• Company Name: ICU MEDICAL, INC.
• Device Count: 500
• 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: true
• Expiration Date: true
• 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	10351688044983 [Primary]
GS1	20351688044980 [Unit of Use]
GS1	30351688044987 [Package]; Contains: 10351688044983; Package: BOX [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K946289

FDA Product Code

• FMI: Needle, hypodermic, single lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2025-04-17
• Device Publish Date: 2017-01-17

On-Brand Devices [Jelco]

• 30351688044987: 4244
• 30351688041856: 4139