FDA UDI
In Commercial Distribution
🇺🇸 United States
JADA System
DI: 00840164521139
·
Model: JADA-2002
·
Organon LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- JADA System
- Primary DI
- 00840164521139
- Version / Model
- JADA-2002
- Company Name
- Organon LLC
- Labeler DUNS
- 117494753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-15
- Public Version
- 1
- Public Version Date
- 2023-02-23
- Public Version Status
- New
- Public Device Record Key
- dc360da0-91a5-4044-b8ff-1eddc611c96b
Device Description
Vacuum-induced Hemorrhage Control System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OQY | Intrauterine tamponade balloon | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61558 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 60840164521131 | GS1 | case | 3 | In Commercial Distribution | |
| Primary | 00840164521139 | GS1 |
Customer Contacts
- Phone
- +1(844)674-3200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212757 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Handle 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.