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Oi Medium

by Organic Initiative Corporation

Oi Medium is a Class II device made by Organic Initiative Corporation, listed in FDA GUDID since 2 Apr 2020 (UDI-DI 09421904034259), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09421904034259 UDI-DI Date2 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Oi
Generic name
Menstrual cup/disc, non-latex, reusable
Model / reference
Medium
Primary DI / UDI-DI
09421904034259
FDA product code
HHE
GMDN term
Menstrual cup/disc, non-latex, reusable
Device class
Class II
Regulation number
884.5400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Menstrual cup/disc, non-latex, reusable

Similar devices

Other devices filed under FDA product code HHE (Cup, Menstrual).

Other devices from Organic Initiative Corporation

See all devices from Organic Initiative Corporation →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)