← Back to catalogue

ProGear/Oxafence

FDA UDI

Class II (US FDA UDI)

by Prestige Ameritech

Identity

Trade Name
ProGear/Oxafence FDA UDI
Generic Name
Surgical/medical face mask, antimicrobial, single-use FDA UDI
Device Name
Antiviral Earloop Mask, ASTM Level 3 FDA UDI
Model / Reference
AV82030 FDA UDI
Description
Antiviral Earloop Mask, ASTM Level 3 FDA UDI

Identifiers

Primary DI / UDI-DI
00852212003719 FDA UDI
FDA Product Code
OUK FDA UDI
GMDN Term
Surgical/medical face mask, 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Surgical/medical face mask, antimicrobial, single-use

ProGear/Oxafence by Prestige Ameritech — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical/medical face mask, antimicrobial, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Prestige Ameritech

Sources (1)

  • FDA UDI 353e04ca-b93e-400b-9c4a-2ea93acd3401 34 fields · synced Jun 9, 2026