Amplatzer 9-TVLPC4F90/080
GUDID 00811806012926
Catheter
AGA MEDICAL CORPORATION
Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit Cardiac occluder delivery kit| Primary Device ID | 00811806012926 |
| NIH Device Record Key | 96d9aef2-9193-4d5f-8f2d-7df52641f671 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Amplatzer |
| Version Model Number | TorqVue™ LP |
| Catalog Number | 9-TVLPC4F90/080 |
| 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 | |
| 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
| Length | 80 Centimeter |
| Length | 80 Centimeter |
| Length | 80 Centimeter |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
| Catheter Gauge | 4 French |
| Length | 80 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811806012926 [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 | 2016-11-23 |
On-Brand Devices [Amplatzer]
| 00811806012926 | Catheter |
| 00811806011257 | Duct Occluder II |
| 00811806011134 | Duct 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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