Careone

FDA UDI

Class II (US FDA UDI)

by Ahold U.S.A., Inc.

Identity

Trade Name: Careone FDA UDI
Generic Name: Vaginal lubricant FDA UDI
Device Name: Personal Lubricant 4oz. (113g) FDA UDI
Model / Reference: 7W926OFC1 FDA UDI
Description: Personal Lubricant 4oz. (113g) FDA UDI

Identifiers

Primary DI / UDI-DI: 00041520314307 FDA UDI
510(k) Number: K180923 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

Careone by Ahold U.S.A., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Vaginal lubricant.

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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
Aloe Cadabra — Live Well Brands, INC. · Class II

Cleared under the same submission

K180923 also covers:

LEADER — Cardinal Health 110, Inc.
HEB — H. E. BUTT GROCERY COMPANY
Good Sense — L PERRIGO COMPANY
Meijer Personal Lubricant — MEIJER, INC.
PUBLIX Personal Lubricant — PUBLIX SUPER MARKETS, INC.
Equaline — SUPERVALU INC.
Up & Up — TARGET CORPORATION
Walgreens — WALGREEN CO.

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

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Manufacturer

Manufacturer: Ahold U.S.A., Inc.

Sources (1)

FDA UDI d86bf8d4-a94c-48a6-96d0-fa033c448b51 34 fields · synced May 30, 2026