Tendyne™ TENDV-WT

GUDID 05415067032027

2 lb Weight

ST. JUDE MEDICAL, INC.

Pressure monitor calibration weight

• Primary Device ID: 05415067032027
• NIH Device Record Key: 5c7f1aff-9e26-4cec-8bb9-496707260592
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tendyne™
• Version Model Number: TENDV-WT
• Catalog Number: TENDV-WT
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Weight: 2 Pound
• Weight: 2 Pound
• Weight: 2 Pound
• Weight: 2 Pound
• Weight: 2 Pound
• Weight: 2 Pound
• Weight: 2 Pound
• Weight: 2 Pound
• Weight: 2 Pound
• Weight: 2 Pound
• Weight: 2 Pound
• Weight: 2 Pound
• Weight: 2 Pound
• Weight: 2 Pound
• Weight: 2 Pound
• Weight: 2 Pound
• Weight: 2 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067032027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240042

FDA Product Code

• NPU: Prosthesis, mitral valve, percutaneously delivered

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

[05415067032027]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-06
• Device Publish Date: 2025-05-29

On-Brand Devices [Tendyne™]

• 05415067046192: Retrieval System
• 05415067032720: Stand Components
• 05415067032713: Pad Positioning System
• 05415067032706: Loading System
• 05415067032690: Delivery System
• 05415067032683: Apical Pad - Large
• 05415067032676: Apical Pad - Small
• 05415067032669: Mitral Valve
• 05415067032652: Mitral Valve
• 05415067032645: Mitral Valve
• 05415067032638: Mitral Valve
• 05415067032621: Mitral Valve
• 05415067032614: Mitral Valve
• 05415067032607: Mitral Valve
• 05415067032591: Mitral Valve
• 05415067032584: Mitral Valve
• 05415067032577: Mitral Valve
• 05415067032560: Mitral Valve
• 05415067032553: Mitral Valve
• 05415067032546: Mitral Valve
• 05415067032539: Mitral Valve
• 05415067032522: Mitral Valve
• 05415067032515: Mitral Valve
• 05415067032508: Mitral Valve
• 05415067032492: Mitral Valve
• 05415067032485: Mitral Valve
• 05415067032478: Mitral Valve
• 05415067032461: Mitral Valve
• 05415067032454: Mitral Valve
• 05415067032447: Mitral Valve
• 05415067032096: Stand
• 05415067032027: 2 lb Weight