FDA UDI
In Commercial Distribution
🇺🇸 United States
Kiwi® OmniCup®
DI: 00814247021243
·
Model: VAC-DUAL MT
·
CLINICAL INNOVATIONS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Kiwi® OmniCup®
- Primary DI
- 00814247021243
- Version / Model
- VAC-DUAL MT
- Company Name
- CLINICAL INNOVATIONS, LLC
- Labeler DUNS
- 809524291
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-16
- Public Version
- 1
- Public Version Date
- 2025-12-24
- Public Version Status
- New
- Public Device Record Key
- d9671eaf-1cf6-4e4e-ad61-780f62f61381
Device Description
Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| HDB | Extractor, Vacuum, Fetal | Obstetrics/Gynecology | 884.4340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37792 | Foetal vacuum extraction system cup, single-use | A suction cap intended to be applied to the scalp of a foetus to facilitate vaginal or Caesarean section delivery by traction. It typically has a soft liner to prevent tissue damage, a connection to the vacuum source, a handgrip for the clinician to apply traction, and may include a vacuum release valve and fluid retention trap. Suction may be provided by an electrically-powered suction pump, the hospital central vacuum system, or a hand-operated vacuum pump. It is typically used for dystocia, uterine inertia, maternal exhaustion, or maternal/foetal distress. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814247021243 | GS1 | ||||
| Package | 10814247021240 | GS1 | Box | 5 | In Commercial Distribution | |
| Package | 20814247021247 | GS1 | Shipper | 12 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250298 | 000 |