Home GUDID 00811806011127 Amplatzer™
Primary DI 00811806011127
Brand Amplatzer™
Company ST. JUDE MEDICAL, INC.
Model 9-PDA-005
Catalog number 9-PDA-005
Device description Duct Occluder
Published 2014-09-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name MAE OCCLUDER, PATENT DUCTUS, ARTERIOSUS
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MAE Occluder, Patent Ductus, Arteriosus Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00811806011127 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 00811806011127 00811806011127 811806011127 0811806011127
GMDN Terms# Term, Definition table Term Definition Cardiac defect occluder An implantable disk-like device intended to be used for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. It is made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester), and is typically self-expandable. The device is used to treat cardiac disorders that may include (but not limited to) atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). Disposable devices dedicated to implantation may be included with the implant.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 0
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 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05415067030979 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067030986 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067030993 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067031006 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067031013 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067031020 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067031037 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067031044 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 05415067031051 Amplatzer Piccolo™ ST. JUDE MEDICAL, INC. MAE 2019-01-18 00811806011189 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-19 00811806011202 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-15 00811806011219 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-15 00811806011233 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-15 00811806011240 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-15 00811806011257 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-15 00811806011264 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-15 00811806011103 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-08 00811806011110 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-08 00811806011134 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-08 00811806011141 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-08 00811806011172 Amplatzer™ ST. JUDE MEDICAL, INC. MAE 2014-09-08 04042301159953 Nit-Occlud PDA pfm medical ag MAE 2014-08-06 04042301159977 Nit-Occlud PDA pfm medical ag MAE 2014-08-06 04042301159991 Nit-Occlud PDA pfm medical ag MAE 2014-08-06 04042301160010 Nit-Occlud PDA pfm medical ag MAE 2014-08-06 04042301160034 Nit-Occlud PDA pfm medical ag MAE 2014-08-06 04042301159939 Nit-Occlud PDA pfm medical ag MAE 2014-08-06 4042301159960 Nit-Occlud PDA pfm medical ag MAE 2014-08-06 4042301159984 Nit-Occlud PDA pfm medical ag MAE 2014-08-06 4042301160003 Nit-Occlud PDA pfm medical ag MAE 2014-08-06
sjm.com