St.Jude Medical™ EX-05

GUDID 05415067009708

ST. JUDE MEDICAL, INC.

Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle

• Primary Device ID: 05415067009708
• NIH Device Record Key: ecad1426-7e07-46a8-880e-1e9566ecbd8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: St.Jude Medical™
• Version Model Number: EX-05
• Catalog Number: EX-05
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067009708 [Primary]

FDA Product Code

• DTI: SIZER, HEART-VALVE, PROSTHESIS

Sterilization

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

[05415067009708]

Moist Heat or Steam Sterilization

[05415067009708]

Moist Heat or Steam Sterilization

[05415067009708]

Moist Heat or Steam Sterilization

[05415067009708]

Moist Heat or Steam Sterilization

[05415067009708]

Moist Heat or Steam Sterilization

[05415067009708]

Moist Heat or Steam Sterilization

[05415067009708]

Moist Heat or Steam Sterilization

[05415067009708]

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: 2015-11-02

On-Brand Devices [St.Jude Medical™]

• 05415067009753: MHV-HHR 9.6"
• 05415067009739: MHV-HHL2 9.6"
• 05415067009722: MHV-HHL1 9.0"
• 05415067009715: HH-05
• 05415067009708: EX-05
• 15415067004779: LT100
• 05415067003942: Mitral valve holder handle
• 05415067003935: 37mm Standard sizer ring
• 05415067003904: Single-ended handle, 31mm Standard sizer
• 05415067003898: Double-ended handle,17mm sizer rings
• 05414734025294: Single-ended handle, 29mm Standard sizer
• 05414734025287: Double-ended handle 27mm sizer rings
• 05414734025263: Double-ended handle, 21mm sizer rings
• 05414734025256: Double-ended handle, 19mm sizer rings
• 05414734023856: Double-ended handle, 23 mm sizer rings
• 05414734010115: Rigid Holder Handle
• 05414734010108: Valve holder handle