SwabTip™ SWTP-5

GUDID 30887709097828

SwabTip Strip

ICU MEDICAL, INC.

Luer-formatted disinfection cap

• Primary Device ID: 30887709097828
• NIH Device Record Key: 63217983-ab0a-4d4e-84ac-73c4d72311fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SwabTip™
• Version Model Number: SWTP-5
• Catalog Number: SWTP-5
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not Freeze

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887709097827 [Primary]
GS1	10887709097824 [Unit of Use]
GS1	20887709097821 [Package]; Contains: 00887709097827; Package: Carton [50 Units]; In Commercial Distribution
GS1	30887709097828 [Package]; Contains: 20887709097821; Package: Case [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190918

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: 2021-08-31
• Device Publish Date: 2021-08-23

Devices Manufactured by ICU MEDICAL, INC.

• 10887709147963 - Bivona: 2025-02-21 FT25BN55NGF117N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709147970 - Bivona: 2025-02-21 FT25BN45NGF124N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709148076 - Bivona: 2025-02-21 FT25BN60NGF115N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709148083 - Bivona: 2025-02-21 FU25BN40NGE122N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709148090 - Bivona: 2025-02-21 FT25BN35NGE123N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709148106 - Bivona: 2025-02-21 FU25BN30NSE126N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709148113 - Bivona: 2025-02-21 FU25BN30NSE127N Bivona DI: Non-Adjustable-Wired_Non-Sterile
• 10887709148120 - Bivona: 2025-02-21 FU25BN40NSA128N Bivona DI: Non-Adjustable-Wired_Non-Sterile