ProGear/Oxafence

GUDID 30852212003710

Antiviral Earloop Mask, ASTM Level 3

PRESTIGE AMERITECH, LTD.

Surgical/medical face mask, antimicrobial, single-use
Primary Device ID30852212003710
NIH Device Record Key44d95a34-cbfa-4053-bc84-5892f6744ae6
Commercial Distribution StatusIn Commercial Distribution
Brand NameProGear/Oxafence
Version Model NumberAV82030-12
Company DUNS199692794
Company NamePRESTIGE AMERITECH, LTD.
Device Count12
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone18664018972
Emailorders@prestigeam.com
Phone18664018972
Emailorders@prestigeam.com
Phone18664018972
Emailorders@prestigeam.com
Phone18664018972
Emailorders@prestigeam.com
Phone18664018972
Emailorders@prestigeam.com
Phone18664018972
Emailorders@prestigeam.com
Phone18664018972
Emailorders@prestigeam.com
Phone18664018972
Emailorders@prestigeam.com
Phone18664018972
Emailorders@prestigeam.com
Phone18664018972
Emailorders@prestigeam.com
Phone18664018972
Emailorders@prestigeam.com
Phone18664018972
Emailorders@prestigeam.com
Phone18664018972
Emailorders@prestigeam.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110852212003716 [Primary]
GS130852212003710 [Package]
Contains: 10852212003716
Package: Case [62 Units]
In Commercial Distribution
GS180852212003715 [Unit of Use]

FDA Product Code

OUKSurgical Mask With Antimicrobial/Antiviral Agent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-21
Device Publish Date2025-01-13

On-Brand Devices [ProGear/Oxafence]

80852212003715Antiviral Earloop Mask, ASTM Level 3
30852212003710Antiviral Earloop Mask, ASTM Level 3

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