ClearGuard™ CGHD-100

GUDID 10887709123585

ClearGuard™ HD 100 Pack

ICU MEDICAL, INC.

Luer-formatted disinfection cap

• Primary Device ID: 10887709123585
• NIH Device Record Key: 13b3ca56-6fbe-4677-a6dc-1e56b47a00fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearGuard™
• Version Model Number: CGHD-100
• Catalog Number: CGHD-100
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887709123588 [Primary]
GS1	10887709123585 [Package]; Contains: 00887709123588; Package: CS [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180111

FDA Product Code

• PEH: Hemodialysis Catheter Luer End Cap

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: 2021-07-19
• Device Publish Date: 2021-07-09

Devices Manufactured by ICU MEDICAL, INC.

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• 10887709171111 - Bivona: 2025-10-07 FT25IN30NGE228N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709171128 - Bivona: 2025-10-07 FT25IN35NGE227N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709171135 - Bivona: 2025-10-07 ST25IN55NSA225N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709171142 - Bivona: 2025-10-07 FU25IN35NGE224N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709171159 - Bivona: 2025-10-07 FU25IN40NGE223N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709171166 - Bivona: 2025-10-07 FU25IN40NGE221S Bivona DI: Non-Adjustable-Wired-Sterile