Identity
- Trade Name
- Monoart FDA UDI
- Generic Name
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
- Device Name
- Graffiti patterned disposable medical face masks, fluid resistant, ideal for aerosol and splash protection. Prevent airborne transmission of microorganisms and ensure excellent breathability, which exceeds the requirements of EN 14683. Equipped with an XTrap filter that captures bacteria and viruses for three times more protection and a particulate and antibacterial filter (99.8% filtration efficiency). Provided with comfortable rounded elastic bands and an elongated nose bridge with a double track for maximum stability. Box of 50 masks. Colour: lilac with pattern FDA UDI
- Model / Reference
- Monoart Face Mask Protection Graffiti FDA UDI
- Description
- Graffiti patterned disposable medical face masks, fluid resistant, ideal for aerosol and splash protection. Prevent airborne transmission of microorganisms and ensure excellent breathability, which exceeds the requirements of EN 14683. Equipped with an XTrap filter that captures bacteria and viruses for three times more protection and a particulate and antibacterial filter (99.8% filtration efficiency). Provided with comfortable rounded elastic bands and an elongated nose bridge with a double track for maximum stability. Box of 50 masks. Colour: lilac with pattern FDA UDI
Identifiers
- Catalog Number
- 217015 FDA UDI
- Primary DI / UDI-DI
- E3072170150 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical/medical face mask, non-antimicrobial, single-use
Monoart by Euronda Spa — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Euronda Spa
Sources (1)
- FDA UDI b18b5c45-9f3d-4334-b470-6fdab2708126 34 fields · synced May 30, 2026