Home GUDID 05414734205191 BRK-1™
Primary DI 05414734205191
Brand BRK-1™
Company ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
Model G407212
Catalog number G407212
Device description XS Transseptal Needle
Published 2015-11-13
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 DRC Trocar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRC Trocar Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05414734205191 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05414734205191 05414734205191 5414734205191
GMDN Terms# Term, Definition table Term Definition Cardiac transseptal needle A device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin stainless steel tube that is curved and pointed at the distal end, usually having a hub with a stopcock and orientation indicators at the proximal end. It may include a stylet for support during handling. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 98 Centimeter Outer Diameter 1.3 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep dry. Keep away from sunlight. Protect from heat and radioactive source Special Storage Condition, Specify 0 0 Store in a Cool, Dark, Dry Location.
Regulatory Flags# DUNS number 040960379 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810212933825 SURGIPROS Surgipros, LLC DRC 2026-07-28 00810212933832 SURGIPROS Surgipros, LLC DRC 2026-07-28 00810212933849 SURGIPROS Surgipros, LLC DRC 2026-07-28 00810212933856 SURGIPROS Surgipros, LLC DRC 2026-07-28 00841731135391 Redemption VILEX LLC DRC 2026-01-12 10192253057218 Argyle Cardinal Health 200, LLC DRC 2024-08-02 10192253057225 Argyle Cardinal Health 200, LLC DRC 2024-08-02 10192253057232 Argyle Cardinal Health 200, LLC DRC 2024-08-02 10192253057249 Argyle Cardinal Health 200, LLC DRC 2024-08-02 10192253057256 Argyle Cardinal Health 200, LLC DRC 2024-08-02 10192253057263 Argyle Cardinal Health 200, LLC DRC 2024-08-02 10192253057287 Argyle Cardinal Health 200, LLC DRC 2024-08-02 10192253065237 Argyle Cardinal Health 200, LLC DRC 2024-08-02 00858769006425 SafeSharp Transseptal Needle PPMDM DRC 2024-07-02 00858769006449 SafeSharp Transseptal Needle PPMDM DRC 2024-07-02 00858769006456 SafeSharp Transseptal Needle PPMDM DRC 2024-07-02 00858769006470 SafeSharp Transseptal Needle PPMDM DRC 2024-07-02 10884450412708 Merit Advance® Merit Medical Systems, Inc. DRC 2024-03-29 00858769006418 SafeSept Transseptal Guidewire PPMDM DRC 2022-09-26 00858769006364 SafeSept Blunt Needle PPMDM DRC 2021-03-15 00858769006371 SafeSept Blunt Needle PPMDM DRC 2021-03-15 00858769006388 SafeSept Blunt Needle PPMDM DRC 2021-03-15 00858769006395 SafeSept Blunt Needle PPMDM DRC 2021-03-15 00858769006401 SafeSept Blunt Needle PPMDM DRC 2021-03-15 M752TSBRF6640 Stradis Medical, LLC STRADIS MEDICAL LLC DRC 2020-10-26 M752TN170313069C0 Stradis Medical, LLC STRADIS MEDICAL LLC DRC 2020-06-16 00849233009059 Busse Hospital Diposables ROBERT BUSSE & CO., INC. DRC 2020-04-08 00858769006197 Transseptal Needle PPMDM DRC 2018-11-28 00858769006203 Transseptal Needle PPMDM DRC 2018-11-28 00858769006210 Transseptal Needle PPMDM DRC 2018-11-28
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