DEVICE: Monoart (E3072171210)
Device Identifier (DI) Information
Monoart
Monoart Face Mask Protection 3
In Commercial Distribution
217121
EURONDA SPA
Monoart Face Mask Protection 3
In Commercial Distribution
217121
EURONDA SPA
Disposable hypo-allergenic face mask, composed by 4 layers:
.Soft, colored and water-repellent non-woven fabric with floral motifs;
.PFE (Particle Filtration Efficiency) filter and BFE (Bacterial Filtration Efficiency)>99%;
.2 layers of comfortable, non-woven cotton lining for extra absorbance of sweat and humidity when used by operators.
It is ideal for protection from dust and aerosols: Δ<3.0 mm H2O/cm2 in accordance with the EN14683 standard (differential pressure: surgical mask breathability rating). Built-in nose bridge.
Colour: floral pink
Box of 50 masks
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35177 | Surgical/medical face mask, single-use |
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FXX | Mask, Surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
60ce2f0f-e330-4e2d-be9c-20b07fca1108
May 06, 2020
2
November 29, 2018
May 06, 2020
2
November 29, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
E3072171211 | 50 | E3072171210 | In Commercial Distribution | BOX | |
E3072171212 | 20 | E3072171211 | In Commercial Distribution | CARTON |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined