Identity
- Trade Name
- DUREX Pleasure Pack Condom FDA UDI
- Generic Name
- Basic male condom, Hevea-latex FDA UDI
- Device Name
- Condom FDA UDI
- Model / Reference
- Condom FDA UDI
- Description
- Condom FDA UDI
Identifiers
- Primary DI / UDI-DI
- 88302340300429 FDA UDI
- FDA Product Code
- HIS FDA UDI
- GMDN Term
- Basic male condom, Hevea-latex FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5300 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
DUREX Pleasure Pack Condom by RB Health (us) LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- RB Health (us) LLC
Sources (1)
- FDA UDI 8c4d9558-2d80-48e6-b639-953c9e3ce87f 36 fields · synced Jun 7, 2026