Amplatzer Piccolo™ 9-PDS-04F-045

GUDID 05415067052926

Delivery System

ST. JUDE MEDICAL, INC.

Cardiac occluder delivery kit

• Primary Device ID: 05415067052926
• NIH Device Record Key: 7552f240-a7d6-40b6-b411-f3cbedf3c682
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amplatzer Piccolo™
• Version Model Number: 9-PDS-04F-045
• Catalog Number: 9-PDS-04F-045
• 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

Device Dimensions

• Length: 45 Centimeter
• Catheter Gauge: 4 French
• Length: 45 Centimeter
• Catheter Gauge: 4 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067052926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252417

FDA Product Code

• DQY: Catheter, percutaneous

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: 2025-12-30
• Device Publish Date: 2025-12-22

On-Brand Devices [Amplatzer Piccolo™]

• 05415067031051: Duct Occluder
• 05415067031044: Duct Occluder
• 05415067031037: Duct Occluder
• 05415067031020: Duct Occluder
• 05415067031013: Duct Occluder
• 05415067031006: Duct Occluder
• 05415067030993: Duct Occluder
• 05415067030986: Duct Occluder
• 05415067030979: Duct Occluder
• 05415067052926: Delivery System