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Careone 7W926OFC1

by Ahold U.S.A., Inc.

Careone 7W926OFC1 is a vaginal lubricant (FDA Class II; FDA product code NUC, Lubricant, Personal) made by Ahold U.S.A., Inc., cleared under FDA 510(k) K180923 on 9 Jul 2018 and listed in FDA GUDID since 11 Oct 2022 (UDI-DI 00041520314307), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K180923

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00041520314307 UDI-DI Date11 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180923 Date9 Jul 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180923 decided 9 Jul 2018 Active
  • FDA GUDID UDI-DI 00041520314307 listed 11 Oct 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180923
  2. Listed FDA GUDID 00041520314307

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Careone
Generic name
Vaginal lubricant
Model / reference
7W926OFC1
Description
Personal Lubricant 4oz. (113g)
Primary DI / UDI-DI
00041520314307
510(k) Number
FDA product code
NUC
GMDN term
Vaginal lubricant
Device class
Class II
Regulation number
884.5300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vaginal lubricant

Cleared under the same submission (K180923)

and 4 more cleared under K180923

Similar devices

Other devices filed under FDA product code NUC (Lubricant, Personal).

Other devices from Ahold U.S.A., Inc.

See all devices from Ahold U.S.A., Inc. →

Properties

  • Over-the-counter
Other properties (14, all answered No)