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Pink

FDA UDI

Class II (US FDA UDI)

by Empowered Products

Identity

Trade Name
Pink FDA UDI
Generic Name
Sexual lubricant FDA UDI
Device Name
2.8oz bottle of water based lubricant intended for use during intercourse or masturbation. FDA UDI
Model / Reference
Water - 2.8oz FDA UDI
Description
2.8oz bottle of water based lubricant intended for use during intercourse or masturbation. FDA UDI

Identifiers

Primary DI / UDI-DI
00891306000463 FDA UDI
510(k) Number
K152918 FDA UDI
FDA Product Code
NUC FDA UDI
GMDN Term
Sexual 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Sexual lubricant

Pink by Empowered Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sexual lubricant.

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Empowered Products

Sources (1)

  • FDA UDI 2bd92439-507a-4e08-9340-f4ce58b69b13 35 fields · synced May 30, 2026