Identity
- Trade Name
- Xen Enzymatic 5L FDA UDI
- Generic Name
- Medical device cleaning agent FDA UDI
- Device Name
- A neutral pH, low-foaming, triple enzyme detergent for cleaning medical instruments and devices using automated washer-disinfectors, including cart washers. FDA UDI
- Model / Reference
- XV1807/5NA FDA UDI
- Description
- A neutral pH, low-foaming, triple enzyme detergent for cleaning medical instruments and devices using automated washer-disinfectors, including cart washers. FDA UDI
Identifiers
- Catalog Number
- 6036002601 FDA UDI
- Primary DI / UDI-DI
- 05060478112075 FDA UDI
- FDA Product Code
- FLG FDA UDI
- GMDN Term
- Medical device cleaning agent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6150 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 Enzymatic 5L 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 c975dce3-fa17-4d3d-98b5-ced796d75e87 35 fields · synced Jun 1, 2026