SwiftSet

GUDID 30884521196777

Topical Skin Adhesive

Covidien LP

Skin-approximation adhesive

• Primary Device ID: 30884521196777
• NIH Device Record Key: 89c44d4e-6763-4913-97ee-04298b007e6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SwiftSet
• Version Model Number: SS6
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Total Volume: 0.8 Milliliter
• Total Volume: 0.8 Milliliter
• Total Volume: 0.8 Milliliter
• Total Volume: 0.8 Milliliter
• Total Volume: 0.8 Milliliter
• Total Volume: 0.8 Milliliter
• Total Volume: 0.8 Milliliter
• Total Volume: 0.8 Milliliter
• Total Volume: 0.8 Milliliter
• Total Volume: 0.8 Milliliter
• Total Volume: 0.8 Milliliter
• Total Volume: 0.8 Milliliter
• Total Volume: 0.8 Milliliter
• Total Volume: 0.8 Milliliter
• Total Volume: 0.8 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521196773 [Primary]
GS1	20884521196770 [Package]; Contains: 10884521196773; Package: PACK_OR_INNER_PACK [6 Units]; In Commercial Distribution
GS1	30884521196777 [Package]; Contains: 20884521196770; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122446

FDA Product Code

• MPN: Tissue adhesive for the topical approximation of skin

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: 2024-05-20
• Device Publish Date: 2017-01-07

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• 20884521703770 - Tri-Staple 2.0: 2024-12-09 Black Extra Thick Circular Reload For use with Signia Circular Adapters
• 20884521822891 - DAR: 2024-12-09 Closed Suction System, Replaceable Catheter Endotracheal Length
• 10884521845480 - Signia: 2024-12-09 SIGNIA CIRCULAR ADAPTER STND LENGTH FT
• 10884521845497 - Signia: 2024-12-09 SIGNIA CIRCULAR ADAPTER XL LENGTH FT
• 20884521581859 - Barrx: 2024-11-18 RFA Cleaning Cap Small
• 20884521581866 - Barrx: 2024-11-18 RFA Cleaning Cap Medium