Amplatzer™ 9-SB-024
GUDID 00811806011523
Sizing Balloon II
AGA MEDICAL CORPORATION
Cardiac sizing catheter| Primary Device ID | 00811806011523 |
| NIH Device Record Key | 9f9eeae3-4054-4f87-a658-744969048732 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Amplatzer™ |
| Version Model Number | Sizing Balloon II |
| Catalog Number | 9-SB-024 |
| 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 | 27 Millimeter |
| Outer Diameter | 27 Millimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 Centimeter |
| Outer Diameter | 24 Millimeter |
| Length | 70 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. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811806011523 [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 |
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