Identity
- Trade Name
- Luwi FDA UDI
- Generic Name
- Female condom, synthetic polymer FDA UDI
- Device Name
- A 4-pack of Luwi Female Condoms. FDA UDI
- Model / Reference
- 4LUWI FDA UDI
- Description
- A 4-pack of Luwi Female Condoms. FDA UDI
Identifiers
- Catalog Number
- 4LUWI FDA UDI
- Primary DI / UDI-DI
- B0244LUWI1 FDA UDI
- PMA Number
- P080002 FDA UDI
- FDA Product Code
- MOL FDA UDI
- GMDN Term
- Female condom, synthetic polymer 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
Yes
FDA UDI
Single Use
Yes
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
Luwi by Luwi, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P080002 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
- Luwi, Llc
Sources (1)
- FDA UDI 91ad0308-1604-4c45-92d1-b8721d5dde05 36 fields · synced May 30, 2026