405545

GUDID 05415067004796

Vessel Dilator

ST. JUDE MEDICAL, INC.

Vascular dilator, single-use

• Primary Device ID: 05415067004796
• NIH Device Record Key: 8235d163-3064-444c-9dfa-3466bb3439e9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 405545
• Catalog Number: 405545
• 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

• Catheter Gauge: 4 French
• Length: 15 Centimeter
• Catheter Gauge: 4 French
• Length: 15 Centimeter
• Catheter Gauge: 4 French
• Length: 15 Centimeter
• Catheter Gauge: 4 French
• Length: 15 Centimeter
• Catheter Gauge: 4 French
• Length: 15 Centimeter
• Catheter Gauge: 4 French
• Length: 15 Centimeter
• Catheter Gauge: 4 French
• Length: 15 Centimeter
• Catheter Gauge: 4 French
• Length: 15 Centimeter
• Catheter Gauge: 4 French
• Length: 15 Centimeter
• Catheter Gauge: 4 French
• Length: 15 Centimeter
• Catheter Gauge: 4 French
• Length: 15 Centimeter
• Catheter Gauge: 4 French
• Length: 15 Centimeter
• Catheter Gauge: 4 French
• Length: 15 Centimeter
• Catheter Gauge: 4 French
• Length: 15 Centimeter
• Catheter Gauge: 4 French
• Length: 15 Centimeter
• Catheter Gauge: 4 French
• Length: 15 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067004796 [Previous]
GS1	05415067042798 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894330

FDA Product Code

• DRE: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

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

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• 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