Regent™ 907

GUDID 05414734030991

ST. JUDE MEDICAL, INC.

Heart valve sizer, reusable

• Primary Device ID: 05414734030991
• NIH Device Record Key: add480de-cf9f-4596-8a42-6cc015668642
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regent™
• Version Model Number: Mechanical Heart Valve Sizer Set
• Catalog Number: 907
• 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: 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
• 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
• 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	05414734030991 [Primary]
GS1	05415067042354 [Primary]

FDA Product Code

• DTI: SIZER, HEART-VALVE, PROSTHESIS

Sterilization

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

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

[05414734030991]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-12-04

On-Brand Devices [Regent™]

• 05414734030991: Mechanical Heart Valve Sizer Set
• 05415067044310: Mechanical Heart Valve
• 05415067044198: Mechanical Heart Valve
• 05415067042958: Mechanical Heart Valve
• 05415067042934: Mechanical Heart Valve