Home GUDID 10827002590943
Bakri
Primary DI 10827002590943
Brand Bakri
Company COOK INCORPORATED
Model G59094
Catalog number J-SOS-100500-V
Device description Bakri Essential Postpartum Balloon
Published 2023-02-28
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 10827002590943 Package GS1 5 In Commercial Distribution 00827002590946 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 10827002590943 10827002590943 00827002590946 00827002590946 827002590946 0827002590946
GMDN Terms# Term, Definition table Term Definition Intrauterine haemostatic balloon catheter A sterile, flexible tube with an inflatable balloon at its distal end intended to be inserted into the uterus and distended with a medium (e.g., sterile water, medical air or other appropriate gas) to reduce postpartum bleeding with pressure. It may have an additional balloon inflated in the upper vagina to seal the uterine cavity. Devices associated with balloon inflation may be included. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in dark, dry, cool place.
Regulatory Flags# DUNS number 042823948 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 true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00840164521139 JADA System Organon LLC OQY 2023-02-15 60840164521131 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