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Astroglide Warming Liquid Personal Lubricant
FDA UDIClass II (US FDA UDI)
by Biofilm, Inc
Identity
- Trade Name
- Astroglide Warming Liquid Personal Lubricant FDA UDI
- Generic Name
- Sexual lubricant FDA UDI
- Device Name
- Astroglide Warming is a personal lubricant for penile, vaginal and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. FDA UDI
- Model / Reference
- 015594010342 FDA UDI
- Description
- Astroglide Warming is a personal lubricant for penile, vaginal and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00015594010342 FDA UDI
- FDA Product Code
- HIS 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2.5 Fluid Ounce FDA UDI
Category: Sexual lubricant
Astroglide Warming Liquid Personal Lubricant by Biofilm, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K041432 also covers:
K221036 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
- Biofilm, Inc
Sources (1)
- FDA UDI ec6a327a-7234-4a32-b07e-3f2ff5da7916 37 fields · synced May 31, 2026