Identity
- Trade Name
- Kiwi® OmniCup® FDA UDI
- Generic Name
- Foetal vacuum extraction system cup, single-use FDA UDI
- Device Name
- Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator FDA UDI
- Model / Reference
- VAC-6000MT FDA UDI
- Description
- Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247020642 FDA UDI
- 510(k) Number
- K981260 FDA UDI
- FDA Product Code
- HDB FDA UDI
- GMDN Term
- Foetal vacuum extraction system cup, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foetal vacuum extraction system cup, single-use
Kiwi® OmniCup® by Clinical Innovations, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K981260 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Clinical Innovations, LLC
Sources (1)
- FDA UDI bb255d00-74e3-4a3f-8651-7fc72e4468b0 34 fields · synced Jun 9, 2026