LT100

GUDID 15415067042313

Mechanical Heart Valve Leaflet Tester

ST. JUDE MEDICAL, INC.

Heart valve prosthesis tester, single-use Heart valve prosthesis tester, single-use Heart valve prosthesis tester, single-use Heart valve prosthesis tester, single-use Heart valve prosthesis tester, single-use Heart valve prosthesis tester, single-use Heart valve prosthesis tester, single-use Heart valve prosthesis tester, single-use Heart valve prosthesis tester, single-use Heart valve prosthesis tester, single-use Heart valve prosthesis tester, single-use Heart valve prosthesis tester, single-use Heart valve prosthesis tester, single-use Heart valve prosthesis tester, single-use Heart valve prosthesis tester, single-use Heart valve prosthesis tester, single-use

• Primary Device ID: 15415067042313
• NIH Device Record Key: 9fde485c-a7a1-4f63-8495-26f2e7b19786
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: LT100
• Catalog Number: LT100
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	05415067004772 [Previous]
GS1	05415067042316 [Primary]
GS1	15415067042313 [Package]; Contains: 05415067042316; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• LXN: PROBE, TEST, HEART-VALVE

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: 2023-05-29
• Device Publish Date: 2023-05-19

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