FDA.reportPublic FDA data

3-Ply Disposable Surgical Face Masks

Primary DI
00850022550003
Brand
3-Ply Disposable Surgical Face Masks
Company
Armbrust Inc.
Model
850022550003
Device description
American Made Surgical Masks, 3-Ply Disposable Surgical Face Masks, ASTM Level 3
Published
2023-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022550003PrimaryGS10
00850022550010Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022550003008500225500038500225500030850022550003
00850022550010008500225500108500225500100850022550010

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical respirator, non-antimicrobial, single-useA form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
512-807-0744support@armbrustusa.com

Regulatory Flags#

DUNS number
117532009
Device count
50

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056441247Target Up&UpGLOVE-ARMBRUST-3.2MIL-BLUE-BOX-1X50-M2026-02-05
85005644124700Target Up&UpGLOVE-ARMBRUST-3.2MIL-BLUE-BOX-1X50-M2026-02-05
00850056441001ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-XS2025-09-24
00850056441018ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-S2025-09-24
00850056441025ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-M2025-09-24
00850056441032ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-l2025-09-24
00850056441049ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-XL2025-09-24
00850056441056ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X90-XXL2025-09-24
85005644100100ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-XS2025-09-24
85005644101800ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-S2025-09-24
85005644102500ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-M2025-09-24
85005644103200ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-l2025-09-24
85005644104900ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-XL2025-09-24
85005644105600ArmbrustGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X90-XXL2025-09-24
00850056441209Target Up&UpGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X50-M2024-12-27
10850056441206Target Up&UpGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X50-M2024-12-27
00850022550218Fold Flat Surgical Mask8500225502182023-01-27
00850022550249American Kid Disposable Face Maks8500225502492023-01-27

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Primary DI, Brand, Company table
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