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eudamed_udi Primary ID: 00814247020628

Kiwi® Vacuum Delivery System, Omni C Cup® for Cesarean Section (UDI 00814247020628)

Manufactured by Clinical Innovations, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Kiwi® Vacuum Delivery System, Omni C Cup® for Cesarean Section - Primary ID 00814247020628

Device Regulatory Overview

The Kiwi® Vacuum Delivery System, Omni C Cup® for Cesarean Section (Model/Catalog Number: VAC-6000C) is a medical device manufactured by Clinical Innovations, LLC. This product is indexed under FDA Product Code / Category Classification Z12080301 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1945-2026 View Full Alert →

Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Descrip...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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ID: Z-0541-2021 View Full Alert →

Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0123-2016 View Full Alert →

The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartu...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
VAC-6000C
Product Code / EMDN
Z12080301
Device Name
Kiwi Complete Vacuum Delivery System
Database Sync Date
2026-08-09 16:51:34

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Kiwi® Vacuum Delivery System, Omni C Cup® for Cesarean Section?

The registered manufacturer of record for Kiwi® Vacuum Delivery System, Omni C Cup® for Cesarean Section is Clinical Innovations, LLC.

What is the Primary UDI-DI identifier for Kiwi® Vacuum Delivery System, Omni C Cup® for Cesarean Section?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00814247020628.

What classification code is assigned to this device?

This device is registered under product classification code Z12080301.

Similar Classification Devices (Z12080301)

Other Devices by Clinical Innovations, LLC

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