St.Jude Medical™ 905-R

GUDID 05414734010115

ST. JUDE MEDICAL, INC.

Heart valve prosthesis sizer handle

• Primary Device ID: 05414734010115
• NIH Device Record Key: 2cc476f6-9ea0-437b-b291-8de60acb9055
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: St.Jude Medical™
• Version Model Number: Rigid Holder Handle
• Catalog Number: 905-R
• 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	05414734010115 [Primary]

FDA Product Code

• DTI: SIZER, HEART-VALVE, PROSTHESIS

Sterilization

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

[05414734010115]

Moist Heat or Steam Sterilization

[05414734010115]

Moist Heat or Steam Sterilization

[05414734010115]

Moist Heat or Steam Sterilization

[05414734010115]

Moist Heat or Steam Sterilization

[05414734010115]

Moist Heat or Steam Sterilization

[05414734010115]

Moist Heat or Steam Sterilization

[05414734010115]

Moist Heat or Steam Sterilization

[05414734010115]

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: 2015-11-13

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