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.

• 10887709128511 - Bivona: 2024-10-09 FT24GN35NGE078N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128528 - Bivona: 2024-10-09 FT24GN35NSE226NBivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128535 - Bivona: 2024-10-09 FT24GN25NSA003N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128542 - Bivona: 2024-10-09 FT24HN60NGF004N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128559 - Bivona: 2024-10-09 FT24HN35NGE005N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128566 - Bivona: 2024-10-09 XT24HS35NGZ006N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
• 10887709128573 - Bivona: 2024-10-09 AU24HS80NSC007N Bivona DI Template: Adjustable Non-Sterile
• 10887709128580 - Bivona: 2024-10-09 FT24HN55NSF008N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile