Aplicare Lubricating Jelly

FDA UDI

Class II (US FDA UDI)

by Aplicare, Inc.

Identity

Trade Name: Aplicare Lubricating Jelly FDA UDI
Generic Name: General-body orifice lubricant FDA UDI
Device Name: Lubricating Jelly FDA UDI
Model / Reference: 82-281 FDA UDI
Description: Lubricating Jelly FDA UDI

Identifiers

Catalog Number: 82-281 FDA UDI
Primary DI / UDI-DI: 00618407002819 FDA UDI
510(k) Number: K912132 FDA UDI
FDA Product Code: FHX FDA UDI
GMDN Term: General-body orifice lubricant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Weight — 5 Gram FDA UDI

Category: General-body orifice lubricant

Aplicare Lubricating Jelly by Aplicare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-body orifice lubricant.

HR Lubricating Jelly — H R Pharmaceuticals, Inc. · Class I
Henry Schein — HENRY SCHEIN, INC. · Class I
NAR Kit — NORTH AMERICAN RESCUE, LLC.
Dukal — Dukal LLC · Class I
PRO ADVANTAGE — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class I
Sterile Bacteriostatic Lubricating Gel — Micro-tech Usa · Class I
DynaLube, Sterile, 2.7 g Packet — Dynarex Corp. · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class I

Cleared under the same submission

K912132 also covers:

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: Aplicare, Inc.

Sources (1)

FDA UDI b9101977-4b46-4725-ac03-873c8965b8be 37 fields · synced May 30, 2026