Astroglide Gel Personal Lubricant

FDA UDI

Class II (US FDA UDI)

by Biofilm, Inc

Identity

Trade Name: Astroglide Gel Personal Lubricant FDA UDI
Generic Name: Sexual lubricant FDA UDI
Device Name: Astroglide Gel is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex and polyurethane condoms. FDA UDI
Model / Reference: 015594012148 FDA UDI
Description: Astroglide Gel is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex and polyurethane condoms. FDA UDI

Identifiers

Primary DI / UDI-DI: 00015594012148 FDA UDI
FDA Product Code: NUC FDA UDI
MMS FDA UDI
GMDN Term: Sexual lubricant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.5300 FDA UDI
880.6375 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 198 Gram FDA UDI

Category: Sexual lubricant

Astroglide Gel Personal Lubricant by Biofilm, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Biofilm, Inc

Sources (1)

FDA UDI e5a8c160-6750-4c6e-b59b-9741d01d48c9 36 fields · synced May 29, 2026