SJM™ 406502

GUDID 15415067009477

REPOSITIONING SLEEVE

ST. JUDE MEDICAL, INC.

Cable/lead/sensor/probe cover, sterile

• Primary Device ID: 15415067009477
• NIH Device Record Key: 955479c4-22a0-4f31-a0d3-b26bf7a51e02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SJM™
• 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: true
• 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

Device Dimensions

• Length: 30 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL,DARK,DRY PLACE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067009470 [Primary]
GS1	15415067009477 [Package]; Contains: 05415067009470; Package: [5 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-04-13

Devices Manufactured by ST. JUDE MEDICAL, INC.

• 05415067051226 - EnSite™: 2025-08-25 X EP System Display Workstation
• 05415067051233 - NA: 2025-08-25 ADAS 3D Base License Software License
• 05415067051257 - EnSite™: 2025-08-25 X EP System Display Workstation
• 05415067051264 - NA: 2025-08-25 ADAS 3D LA License Software License
• 05415067051295 - NA: 2025-08-25 ADAS 3D LV License Temporary Software License
• 05415067051301 - NA: 2025-08-25 ADAS 3D LV License Software License
• 05415067051318 - NA: 2025-08-25 ADAS 3D LA License Temporary Software License
• 05415067051646 - EnSite™: 2025-08-25 X EP System PFA ECG Signal Splitter