Home GUDID 00850017882003 Jada™ System
Primary DI 00850017882003
Brand Jada™ System
Company Alydia Health, Inc.
Model JADA-1001
Catalog number JADA-1001
Device description Jada™ SystemVacuum-induced Hemorrhage Control System
Published 2020-10-15
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 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 00850017882003 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 00850017882003 00850017882003 850017882003 0850017882003
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 Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.
Regulatory Flags# DUNS number 077887522 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices Sharing Product Codes# 
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