FDA.reportPublic FDA data

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

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
K201199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201199000Jada SystemAlydia Health2020-08-28OQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017882003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017882003008500178820038500178820030850017882003

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, Specify00Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (844) 523-2666cs@alydiahealth.com

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#

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
00893029002854JADA 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
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