Home GUDID 60840164521131
JADA System
Primary DI 60840164521131
Brand JADA System
Company Organon LLC
Model JADA-2002
Device description Vacuum-induced Hemorrhage Control System
Published 2023-02-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name OQY Intrauterine tamponade balloon
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OQY Intrauterine Tamponade Balloon Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 60840164521131 Package GS1 3 In Commercial Distribution 00840164521139 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 60840164521131 60840164521131 00840164521139 00840164521139 840164521139 0840164521139
GMDN Terms# Term, Definition table Term Definition Intrauterine haemostatic suction catheter A sterile, flexible tube with a fenestrated loop at its distal end intended to be connected to a vacuum supply and inserted into the uterus to reduce postpartum bleeding through aspiration of blood/debris and induction of uterine contractions. It may have an additional balloon inflated in the upper vagina to seal the uterine cavity. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Handle with care. Do not store in direct sunlight. Store in original packaging in a dry location. Do not use if package is damaged. Consult instructions for use.
Regulatory Flags# DUNS number 117494753 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label true 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 00888937027846 Bakri® Coopersurgical, Inc. OQY 2025-12-10 00888937027853 Bakri® Coopersurgical, Inc. OQY 2025-12-10 00827002590946 Bakri COOK INCORPORATED OQY 2023-02-28 10827002590943 Bakri COOK INCORPORATED OQY 2023-02-28 00840164521139 JADA System Organon LLC OQY 2023-02-15 00850017882003 Jada™ System Alydia Health, Inc. OQY 2020-10-15 10827002242378 Bakri COOK INCORPORATED OQY 2016-09-24 10827002306735 Bakri COOK INCORPORATED OQY 2016-09-24 H671BTC1000 BT-CATH UTAH MEDICAL PRODUCTS, INC. OQY 2016-09-23 H671BTCESY0 BT-CATH UTAH MEDICAL PRODUCTS, INC. OQY 2016-09-23 H671BTC1001 BT-CATH UTAH MEDICAL PRODUCTS, INC. OQY 2016-09-23 H671BTCESY1 BT-CATH UTAH MEDICAL PRODUCTS, INC. OQY 2016-09-23 00814247020765 Ebb® Complete Tamponade System CLINICAL INNOVATIONS, LLC OQY 2016-09-01