DEVICE: ProGear/Oxafence (10852212003716)
Device Identifier (DI) Information
ProGear/Oxafence
AV82030-12
In Commercial Distribution
PRESTIGE AMERITECH, LTD.
AV82030-12
In Commercial Distribution
PRESTIGE AMERITECH, LTD.
Antiviral Earloop Mask, ASTM Level 3
Device Characteristics
MR Unsafe | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
66197 | Surgical/medical face mask, antimicrobial, 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). It includes an antimicrobial/antiviral agent to prevent/inhibit the proliferation of microbes under specified conditions and 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. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OUK | Surgical Mask With Antimicrobial/Antiviral Agent |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
44d95a34-cbfa-4053-bc84-5892f6744ae6
January 21, 2025
1
January 13, 2025
January 21, 2025
1
January 13, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
30852212003710 | 62 | 10852212003716 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
80852212003715
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
18664018972
orders@prestigeam.com
orders@prestigeam.com