JADA System

Primary DI
00840164521139
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
Sterile
true
Single use
true

Contact Domains#

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
K212757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212757000Jada SystemAlydia Health2021-09-30OQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60840164521131PackageGS13In Commercial Distribution
00840164521139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6084016452113160840164521131
00840164521139008401645211398401645211390840164521139

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Handle 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.

Contacts#

Phone, Email table
PhoneEmail
+1(844)674-3200dpoc.us@organon.com

Regulatory Flags#

DUNS number
117494753
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10378206189018XACIATO10482282024-09-13
00840164519440FOLLISTIM PEN STARTER KIT10449422024-01-01
00840164519457FOLLISTIM PEN STARTER KIT SAM10449432024-01-01
00378206129017FOLLISTIM AQ CARTRIDGE 300IU10446152024-01-01
00378206129598FOLLISTIM AQ CARTRIDGE 300IU SAM10448012024-01-01
00378206130013FOLLISTIM AQ CARTRIDGE 600IU10446162024-01-01
00378206130594FOLLISTIM AQ CARTRIDGE 600IU SAM10448002024-01-01
00378206131010FOLLISTIM AQ CARTRIDGE 900IU10446172024-01-01
60378206129019FOLLISTIM AQ CARTRIDGE 300IU10446152024-01-01
60378206129590FOLLISTIM AQ CARTRIDGE 300IU SAM10448012024-01-01
60378206130015FOLLISTIM AQ CARTRIDGE 600IU10446162024-01-01
60378206130596FOLLISTIM AQ CARTRIDGE 600IU SAM10448002024-01-01
60378206131012FOLLISTIM AQ CARTRIDGE 900IU10446172024-01-01
60840164519442FOLLISTIM PEN STARTER KIT10449422024-01-01
60840164519459FOLLISTIM PEN STARTER KIT SAM10449432024-01-01
60840164521131JADA SystemJADA-20022023-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937027846Bakri®Coopersurgical, Inc.OQY2025-12-10
00888937027853Bakri®Coopersurgical, Inc.OQY2025-12-10
00827002590946BakriCOOK INCORPORATEDOQY2023-02-28
10827002590943BakriCOOK INCORPORATEDOQY2023-02-28
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