Kroger

FDA UDI

Class II (US FDA UDI)

by Kroger Co., The

Identity

Trade Name: Kroger FDA UDI
Generic Name: Vaginal lubricant FDA UDI
Device Name: Lubricating Jelly 4oz (113g) FDA UDI
Model / Reference: 7W92645C2 FDA UDI
Description: Lubricating Jelly 4oz (113g) FDA UDI

Identifiers

Primary DI / UDI-DI: 00011110384492 FDA UDI
510(k) Number: K012203 FDA UDI
FDA Product Code: NUC FDA UDI
GMDN Term: Vaginal lubricant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.5300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Vaginal lubricant

Kroger by Kroger Co., The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vaginal lubricant.

Careone — Ahold U.S.A., Inc. · Class II
Breeze by Rexall — DOLGENCORP, LLC · Class II
Durex Cheeky Play Silicone Long Lasting Pleasure/Durex Cheeky Play Silicone — RB Health (us) LLC · Class II
DUREX Massage & Play - Intensify 2 in 1 Lubricant - Guarana — RB Health (us) LLC · Class II
Conceive Plus — Sasmar Pharmaceuticals SPRL · Class II
KY Love Passion Couples Lubricant — RB Health (us) LLC · Class II
Aloe Cadabra — Live Well Brands, INC. · Class II
2.5 oz Silky Moisture Personal Lubricant — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class II

Cleared under the same submission

K012203 also covers:

Signature Care — BETTER LIVING BRANDS LLC
Breeze by Rexall — DOLGENCORP, LLC
DG Health — DOLGENCORP, LLC
Top Care — Topco Associates, LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Kroger Co., The

Sources (1)

FDA UDI abb9f37f-6110-4c09-bc5c-0454ce9ae256 34 fields · synced May 30, 2026