FDA.reportPublic FDA data

Fold Flat Surgical Mask

Primary DI
00850022550218
Brand
Fold Flat Surgical Mask
Company
Armbrust Inc.
Model
850022550218
Device description
Flat Fold Surgical Mask, Behind the ears loops, ASTM F2100 Level 3 Rating
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212740000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212740000Puravita Medical Fold Flat Surgical MaskPuravita M, LLC2021-12-02FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022550218PrimaryGS10
00850022550256Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022550218008500225502188500225502180850022550218
00850022550256008500225502568500225502560850022550256

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry place. Avoid excessive heat about 140 degrees F.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117532009
Device count
20

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
008500225500033-Ply Disposable Surgical Face Masks8500225500032023-01-27
00850022550249American Kid Disposable Face Maks8500225502492023-01-27

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Primary DI, Brand, Company table
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00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
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10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
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10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
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