AMPLATZER™ 9-ITV07F45/80

GUDID 00811806010816

Delivery System

AGA MEDICAL CORPORATION

Cardiac occluder delivery kit

• Primary Device ID: 00811806010816
• NIH Device Record Key: a2ff3310-5919-486e-90cd-6530c3ce881e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMPLATZER™
• Version Model Number: TorqVue™ 45
• Catalog Number: 9-ITV07F45/80
• Company DUNS: 966215829
• Company Name: AGA MEDICAL CORPORATION
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Device Dimensions

• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French
• Catheter Gauge: 7 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN DRY PLACE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811806010816 [Primary]

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-03-09

On-Brand Devices [AMPLATZER™ ]

• 00811806014111: Delivery Sheath
• 00811806012551: Delivery Sheath
• 00811806012513: Delivery Sheath
• 00811806012476: Delivery Sheath
• 00811806012117: Delivery Sheath
• 00811806012100: Delivery Sheath
• 00811806012094: Delivery Sheath
• 00811806011592: Delivery System
• 00811806011585: Delivery System
• 00811806011578: Delivery System
• 00811806011561: Delivery System
• 00811806011509: Vascular Plug
• 00811806011493: Vascular Plug
• 00811806011486: Vascular Plug
• 00811806011479: Vascular Plug
• 00811806011462: Vascular Plug
• 00811806011455: Vascular Plug
• 00811806011448: Vascular Plug
• 00811806010885: Delivery System
• 00811806010878: Delivery System
• 00811806010861: Delivery System
• 00811806010854: Delivery System
• 00811806010847: Delivery System
• 00811806010830: Delivery System
• 00811806010823: Delivery System
• 00811806010816: Delivery System
• 00811806010809: Delivery System
• 00811806010793: Delivery System
• 00811806010786: Delivery System
• 00811806010779: Delivery System
• 00811806010762: Delivery System
• 00811806010755: Delivery System
• 00811806010663: Exchange System
• 00811806010441: Vascular Plug II
• 00811806010434: Vascular Plug II
• 00811806010427: Vascular Plug II
• 00811806010410: Vascular Plug II
• 00811806010403: Vascular Plug II
• 00811806010397: Vascular Plug II
• 00811806010380: Vascular Plug II
• 00811806010373: Vascular Plug II
• 00811806010366: Vascular Plug II
• 00811806010359: Vascular Plug II
• 00811806010342: Vascular Plug II
• 05415067019370: 9-ASD-038
• 05415067019363: Septal Occluder
• 05415067019356: Septal Occluder
• 05415067019349: Septal Occluder
• 05415067019332: 9-ASD-030
• 05415067019325: Septal Occluder