AMPLATZER™ 9-ITV12F45/80
GUDID 00811806010885
Delivery System
AGA MEDICAL CORPORATION
Cardiac occluder delivery kit| Primary Device ID | 00811806010885 |
| NIH Device Record Key | 24efbbe6-b5cd-4dae-bf61-11ee5f1975b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMPLATZER™ |
| Version Model Number | TorqVue™ 45 |
| Catalog Number | 9-ITV12F45/80 |
| 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 |
| 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
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 French |
| Catheter Gauge | 12 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 | 00811806010885 [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 |
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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