Home GUDID 00811806011530 Amplatzer™
Primary DI 00811806011530
Brand Amplatzer™
Company ST. JUDE MEDICAL, INC.
Model 9-SB-034
Catalog number 9-SB-034
Device description Sizing Balloon II
Published 2016-01-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MJN Catheter, intravascular occluding, temporary
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MJN Catheter, Intravascular Occluding, Temporary Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00811806011530 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00811806011530 00811806011530 811806011530 0811806011530
GMDN Terms# Term, Definition table Term Definition Cardiac sizing catheter A sterile flexible tube with an inflatable balloon at the distal end designed for use in a patient with a cardiovascular defect wherein accurate measurement of the defect is important to select the appropriately sized occlusion device. It is typically designed to pass over a guidewire and it will have radiopaque marker bands along it distal end to assist in placement using fluoroscopy. It is made of plastic materials and metal [e, g, platinum (Pt) for the bands] and is available in a variety of designs and sizes. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 70 Centimeter Outer Diameter 34 Millimeter Outer Diameter 40 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep dry.
Regulatory Flags# DUNS number 149818952 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810060550816 Bridge Plus occlusion balloon Philips Image Guided Therapy Corporation MJN 2025-10-09 00850001105118 Prytime Medical Devices, Inc. Prytime Medical Devices, Inc. MJN 2025-06-20 00842429117545 SCEPTER Microvention, Inc. MJN 2025-04-30 00842429117552 SCEPTER Microvention, Inc. MJN 2025-04-30 00842429117569 SCEPTER Microvention, Inc. MJN 2025-04-30 00842429117583 SCEPTER Microvention, Inc. MJN 2025-04-30 00842429106884 Balloon Catheter Microvention, Inc. MJN 2025-04-22 00842429106891 Balloon Catheter Microvention, Inc. MJN 2025-04-22 00842429106907 Balloon Catheter Microvention, Inc. MJN 2025-04-22 00842429106945 Balloon Catheter Microvention, Inc. MJN 2025-04-22 10628678061054 COBRA-OS® Front Line Medical Technologies Inc. MJN 2024-03-22 10628678061061 Syringe, 10 mL Front Line Medical Technologies Inc. MJN 2024-03-22 B090LRN0590 LANDMARK ZIEN MEDICAL TECHNOLOGIES, INC. MJN 2024-01-23 B090LRN0591 LANDMARK ZIEN MEDICAL TECHNOLOGIES, INC. MJN 2024-01-23 10628678061009 COBRA-OS™ Front Line Medical Technologies Inc. MJN 2023-08-25 10628678061016 COBRA-OS™ Front Line Medical Technologies Inc. MJN 2023-08-25 10628678061023 Syringe, 10 mL Front Line Medical Technologies Inc. MJN 2023-08-25 20763000293424 Cadence ™ Precision Injector Thread 1 mL Syringe Micro Therapeutics, Inc. MJN 2022-12-23 00850001105057 Prytime Medical Devices Inc. Prytime Medical Devices, Inc. MJN 2022-12-15 00850001105064 Prytime Medical Devices, Inc. Prytime Medical Devices, Inc. MJN 2022-12-15 00842429103388 Balloon Catheter Microvention, Inc. MJN 2022-06-14 00842429103395 Balloon Catheter Microvention, Inc. MJN 2022-06-14 00842429103401 Balloon Catheter Microvention, Inc. MJN 2022-06-14 00842429103418 Balloon Catheter Microvention, Inc. MJN 2022-06-14 00853359008414 Sniper Embolx, Inc. MJN 2022-05-18 16286780610016 COBRA-OS™ Front Line Medical Technologies Inc. MJN 2022-02-09 16286780610023 Syringe, 10 mL Front Line Medical Technologies Inc. MJN 2022-02-09 16286780610009 COBRA-OS™ Front Line Medical Technologies Inc. MJN 2022-01-28 00853892004447 Terumo Aortic Balloon QXMEDICAL MJN 2021-09-03 00857545008011 Walrus Q'APEL MEDICAL LLC MJN 2021-06-29
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