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KY Personal Lubricant Jelly 00067981993691

by Reckitt Benckiser LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00067981993691 UDI-DI Date9 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1547-2022 FDA Class II initiated 23 Jun 2022

    Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
KY Personal Lubricant Jelly
Generic Name
Vaginal lubricant
Model / Reference
00067981993691
Primary DI / UDI-DI
00067981993691
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

Cleared under the same submission (K201186)

Other devices from Reckitt Benckiser LLC

See all devices from Reckitt Benckiser LLC →

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No