Skip to content

Wellness - Dilator Kit - Purple

by Blush Novelties

Wellness - Dilator Kit - Purple (BL-444111) is a Class I device made by Blush Novelties, listed in FDA GUDID since 17 Aug 2023 (UDI-DI 00819835023425), 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 Number00819835023425 UDI-DI Date17 Aug 2023ListedStatusListed 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  • Withdrawn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
Wellness
Generic name
Vaginal dilator
Model / Ref / Catalog
Wellness - Dilator Kit - Purple, BL-444111
Primary DI / UDI-DI
00819835023425
FDA product code
HDQ
GMDN term
Vaginal dilator
Device class
Class I
Regulation number
884.4530
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code HDQ (Dilator, Cervical, Fixed Size).

Other devices from Blush Novelties

See all devices from Blush Novelties →

Properties

  • Over-the-counter
  • Convenience kit
  • Premarket exempt
Other properties (12, all answered No)