SwabSleeve™ SCXT3-5-2000

GUDID 30887709097101

SwabSleeve™

ICU MEDICAL, INC.

Luer-formatted disinfection cap

• Primary Device ID: 30887709097101
• NIH Device Record Key: e4046ddd-a75c-426d-a071-c5e5d3be31a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SwabSleeve™
• Version Model Number: SCXT3-5-2000
• Catalog Number: SCXT3-5-2000
• Company DUNS: 118380146
• Company Name: ICU MEDICAL, INC.
• Device Count: 5
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887709097100 [Unit of Use]
GS1	10887709097107 [Primary]
GS1	20887709097104 [Package]; Contains: 10887709097107; Package: [50 Units]; In Commercial Distribution
GS1	30887709097101 [Package]; Contains: 20887709097104; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130975

FDA Product Code

• QBP: Cap, device disinfectant

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: 2024-04-15
• Device Publish Date: 2024-04-05

Devices Manufactured by ICU MEDICAL, INC.

• 10887709147192 - Bivona: 2025-03-06 AP25AS50NGA278S Bivona DI: Adjustable - Sterile
• 10887709147208 - Bivona: 2025-03-06 AP25AS45NGA277S Bivona DI: Adjustable - Sterile
• 10887709147215 - Bivona: 2025-03-06 AP25AS40NGA276S Bivona DI: Adjustable - Sterile
• 10887709149615 - Bivona: 2025-03-06 FT25BN40NSE257N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709149622 - Bivona: 2025-03-06 FT25BN35NSE258N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709149639 - Bivona: 2025-03-06 FT25BN40NGE259N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709149646 - Bivona: 2025-03-06 FT25BN35NGE260N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709149653 - Bivona: 2025-03-06 SU24EN45NGF183S Bivona DI: Non-Adjustable-Non-Wired-Sterile