JADA System

Primary DI
00893029002854
Brand
JADA System
Company
GI Supply, Inc.
Model
500063
Device description
Vacuum-induced Hemorrhage Control System
Published
2026-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OQYIntrauterine Tamponade Balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQYIntrauterine Tamponade BalloonObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253642000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253642000Jada System (Jada-2002)Organon, LLC2026-05-15OQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00893029002861PackageGS13In Commercial Distribution
10893029002851PackageGS11In Commercial Distribution
00893029002854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00893029002861008930290028618930290028610893029002861
1089302900285110893029002851
00893029002854008930290028548930290028540893029002854

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine haemostatic suction catheterA 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.

Regulatory Flags#

DUNS number
160990313
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00893029002762JADA System10471962026-07-17
00893029002786JADA System5000512026-07-17
00893029002809JADA System5000622026-07-17
00893029002823JADA System5000522026-07-17
00893029002830JADA System8000126/5000612026-07-17
00893029002878JADA System10501372026-07-17
00893029002892JADA System10503452026-07-17
00893029002595MoonPants SMGIS-7-SMGIS-7-SM2021-07-20
00893029002601MoonPants MLGIS-7-MLGIS-7ML2021-07-20
00893029002618MoonPants XLGIS-7-XLGIS-7-XL2021-07-20
00893029002625MoonPants LongGIS-13GIS-132021-07-20
00893029002632SportShorts XSSL-9XSSL-9XS2021-07-20
00893029002649SportShorts SMSL-9SMSL-9SM2021-07-20
00893029002656SportShorts MLSL-9MLSL-9ML2021-07-20
00893029002663SportShorts XLSL-9XLSL-9XL2021-07-20
00893029002243EverLiftGIS-59GIS-592021-02-18
00893029002229EverLiftGIS-55GIS-552021-02-18
00893029002236RenovaRPGIS-31GIS-312021-07-08
00893029002175RenovaRPGIS-32GIS-322021-07-06
00893029002731RenovaRPGIS-35GIS-352023-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00893029002762JADA SystemGI Supply, Inc.OQY2026-07-17
00893029002786JADA SystemGI Supply, Inc.OQY2026-07-17
00893029002809JADA SystemGI Supply, Inc.OQY2026-07-17
00893029002823JADA SystemGI Supply, Inc.OQY2026-07-17
00893029002830JADA SystemGI Supply, Inc.OQY2026-07-17
00893029002878JADA SystemGI Supply, Inc.OQY2026-07-17
00893029002892JADA SystemGI Supply, Inc.OQY2026-07-17
00888937027846Bakri®Coopersurgical, Inc.OQY2025-12-10
00888937027853Bakri®Coopersurgical, Inc.OQY2025-12-10
00827002590946BakriCOOK INCORPORATEDOQY2023-02-28
10827002590943BakriCOOK INCORPORATEDOQY2023-02-28
00840164521139JADA SystemOrganon LLCOQY2023-02-15
60840164521131JADA SystemOrganon LLCOQY2023-02-15
00850017882003Jada™ SystemAlydia Health, Inc.OQY2020-10-15
10827002242378BakriCOOK INCORPORATEDOQY2016-09-24
10827002306735BakriCOOK INCORPORATEDOQY2016-09-24
H671BTC1000BT-CATHUTAH MEDICAL PRODUCTS, INC.OQY2016-09-23
H671BTCESY0BT-CATHUTAH MEDICAL PRODUCTS, INC.OQY2016-09-23
H671BTC1001BT-CATHUTAH MEDICAL PRODUCTS, INC.OQY2016-09-23
H671BTCESY1BT-CATHUTAH MEDICAL PRODUCTS, INC.OQY2016-09-23
00814247020765Ebb® Complete Tamponade SystemCLINICAL INNOVATIONS, LLCOQY2016-09-01