DEVICE: Monoart (E3072171340)
Device Identifier (DI) Information
Monoart
Monoart Face Mask Protection 4
In Commercial Distribution
217134
EURONDA SPA
Monoart Face Mask Protection 4
In Commercial Distribution
217134
EURONDA SPA
Disposable, hypo-allergenic face mask with 4 layers: a soft water-repellent non-woven fabric for unparalleled protection from dust and moisture; PFE and BFE (Particle Filtration Efficiency and Bacterial Filtration Efficiency) filter > 99%; a polymeric filter for excellent fluid resistance, 120 mmHg; a comfortable non-woven cotton lining for extra absorbance of sweat and humidity when used by operators. Built-in nose bridge.
Box of 50 masks.
Colour: Green
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
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No |
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 |
---|---|
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
56106943-23cd-4061-a463-74db065967c9
May 06, 2020
2
November 28, 2019
May 06, 2020
2
November 28, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
E3072171342 | 20 | E3072171341 | In Commercial Distribution | CARTON | |
E3072171341 | 50 | E3072171340 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
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