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Kiwi® OmniCup® VAC-DUAL MT

by Clinical Innovations, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00814247021243 UDI-DI Date16 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Kiwi® OmniCup®
Generic Name
Foetal vacuum extraction system cup, single-use
Model / Reference
VAC-DUAL MT
Primary DI / UDI-DI
00814247021243
510(k) Number
FDA Product Code
HDB
GMDN Term
Foetal vacuum extraction system cup, single-use
Device Class
Class II
Regulation Number
884.4340
GUDID distribution status
In Commercial Distribution

Other devices from Clinical Innovations, LLC

See all devices from Clinical Innovations, LLC →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No