Identity
- Trade Name
- Xen Xcelerate+ Lumen FDA UDI
- Generic Name
- Medical device cleaning agent FDA UDI
- Device Name
- 16 fl oz aerosol foam spray for use in pre-treatment applications for lumened instruments at point of use and/or during reprocessing delays. FDA UDI
- Model / Reference
- XV1LMN/500NA FDA UDI
- Description
- 16 fl oz aerosol foam spray for use in pre-treatment applications for lumened instruments at point of use and/or during reprocessing delays. FDA UDI
Identifiers
- Catalog Number
- 6036005601 FDA UDI
- Primary DI / UDI-DI
- 05060478112389 FDA UDI
- FDA Product Code
- MNL FDA UDI
- GMDN Term
- Medical device cleaning agent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical device cleaning agent
Xen Xcelerate+ Lumen by Quadralene Limited — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Quadralene Limited
Sources (1)
- FDA UDI 38b945fa-53a8-40dd-992f-e77c74ceb973 35 fields · synced Jun 8, 2026