AMPLATZER™ 9-TV45X45-09F-100

GUDID 00811806012087

Delivery Sheath

AGA MEDICAL CORPORATION

Cardiac occluder delivery kit

• Primary Device ID: 00811806012087
• NIH Device Record Key: c0f11ac7-7a6c-4e8e-bbd7-5e36e9ebfa93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMPLATZER™
• Version Model Number: TorqVue™ 45 x 45
• Catalog Number: 9-TV45X45-09F-100
• 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: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 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	00811806012087 [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™]

• 00811806012384: Vascular Plug 4
• 00811806012377: Vascular Plug 4
• 00811806012360: Vascular Plug 4
• 00811806012353: Vascular Plug 4
• 00811806012346: Vascular Plug 4
• 00811806012087: Delivery Sheath
• 00811806011851: VSD Muscular Occluder
• 00811806011844: VSD Muscular Occluder
• 00811806011837: VSD Muscular Occluder
• 00811806011820: VSD Muscular Occluder
• 00811806011813: VSD Muscular Occluder
• 00811806011806: VSD Muscular Occluder
• 00811806011790: VSD Muscular Occluder
• 00811806011783: VSD Muscular Occluder
• 00811806011530: Sizing Balloon II
• 00811806011523: Sizing Balloon II
• 00811806011516: Sizing Balloon II
• 00811806011264: Duct Occluder II
• 00811806011240: Duct Occluder II
• 00811806011233: Duct Occluder II
• 00811806011219: Duct Occluder II
• 00811806011202: Duct Occluder II
• 00811806011189: Duct Occluder II
• 00811806011172: Duct Occluder II
• 00811806011141: Duct Occluder
• 00811806011127: Duct Occluder
• 00811806011110: Duct Occluder
• 00811806011103: Duct Occluder
• 00811806010748: Guidewire
• 00811806010731: Guidewire
• 00811806010724: Guidewire
• 00811806010717: Guidewire
• 00811806010649: Exchange System
• 00811806010632: Exchange System
• 00811806010625: Exchange System
• 00811806010335: Sizing Plate
• 00811806010311: MF Septal Occluder Cribriform
• 00811806010304: MF Septal Occluder Cribriform
• 00811806010298: MF Septal Occluder Cribriform
• 00811806010281: MF Septal Occluder Cribriform
• 00811806010267: Septal Occluder
• 00811806010250: Septal Occluder
• 00811806010243: Septal Occluder
• 00811806010236: Septal Occluder
• 00811806010229: Septal Occluder
• 00811806010212: Septal Occluder
• 00811806010205: Septal Occluder
• 00811806010199: Septal Occluder
• 00811806010182: Septal Occluder
• 00811806010175: Septal Occluder