406502

GUDID 05415067042859

Repositioning Sleeve

ST. JUDE MEDICAL, INC.

Cardiovascular catheter sheath

• Primary Device ID: 05415067042859
• NIH Device Record Key: 67286429-1b48-4922-b983-7d5f7a3a341b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 406502
• Catalog Number: 406502
• Company DUNS: 149818952
• Company Name: ST. JUDE 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry area

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067009470 [Previous]
GS1	05415067042859 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K884478

FDA Product Code

• DQR: CANNULA, CATHETER

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: 2022-02-24
• Device Publish Date: 2022-02-16

Devices Manufactured by ST. JUDE MEDICAL, INC.

• 05415067055613 - EnSite™: 2026-01-16 X EP System Software Upgrade
• 05415067051417 - Current™: 2026-01-14 PFA Radiolucent ECG Lead Set
• 05415067051516 - Current™: 2026-01-14 PFA Generator
• 05415067051554 - Current™: 2026-01-14 PFA ECG Trunk Cable
• 05415067051615 - Current™: 2026-01-14 PFA Radiopaque ECG Lead Set
• 05415067051721 - Current™: 2026-01-14 PFA Generator Cart
• 05415067051752 - Current™: 2026-01-14 PFA Generator
• 05415067051813 - Current™: 2026-01-14 PFA Recording System Connect Cable