AMPLATZER™ 9-ASD-009
GUDID 05415067019172
Septal Occluder
AGA MEDICAL CORPORATION
Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder Cardiac defect occluder| Primary Device ID | 05415067019172 |
| NIH Device Record Key | 57cebf0c-9255-4a39-b3a4-0b72cfe0c7a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMPLATZER™ |
| Version Model Number | 9-ASD-009 |
| Catalog Number | 9-ASD-009 |
| Company DUNS | 966215829 |
| Company Name | AGA MEDICAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Device Dimensions
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
| Outer Diameter | 9 Millimeter |
Operating and Storage Conditions
| 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. |
| 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. |
| 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 | 05415067019172 [Primary] |
FDA Product Code
| MLV | Transcatheter septal occluder |
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 | 2015-01-27 |
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 |
Trademark Results [AMPLATZER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMPLATZER 75263094 2144604 Live/Registered |
ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC. 1997-03-24 |
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