Amplatzer™ 9-SB-018
GUDID 00811806011516
Sizing Balloon II
AGA MEDICAL CORPORATION
Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter Cardiac sizing catheter| Primary Device ID | 00811806011516 |
| NIH Device Record Key | f1229475-f7c1-47e6-98dc-6d50a6074b5e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Amplatzer™ |
| Version Model Number | Sizing Balloon II |
| Catalog Number | 9-SB-018 |
| 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 |
Device Dimensions
| Outer Diameter | 20 Millimeter |
| Outer Diameter | 20 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 18 Millimeter |
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. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811806011516 [Primary] |
FDA Product Code
| MJN | Catheter, intravascular occluding, temporary |
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 | 2016-01-15 |
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 |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.