FDA.reportPublic FDA data

Target Up&Up

Primary DI
00850056441261
Brand
Target Up&Up
Company
Armbrust Inc.
Model
850056441261
Device description
Medical Kids Face Mask 10 pack
Published
2026-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical
OXZPediatric/Child Facemask

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2
OXZPediatric/Child FacemaskGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211520000Amerishield Surgical MaskPremiumestore, LLC2021-06-15FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056441261PrimaryGS10
85005644126100Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056441261008500564412618500564412610850056441261
8500564412610085005644126100

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.

Regulatory Flags#

DUNS number
117532009
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056441254Target Up&Up8500564412542026-06-25
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
00850022550218Fold Flat Surgical Mask8500225502182023-01-27
00850022550249American Kid Disposable Face Maks8500225502492023-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086117037Resilient Medical SolutionsResilient Medical Solutions, LLCFXX2026-07-08
00840456202722JMUJMU DENTAL, INCFXX2026-07-07
00840456202739JMUJMU DENTAL, INCFXX2026-07-07
00840456202746JMUJMU DENTAL, INCFXX2026-07-07
00840456214619JMUJMU DENTAL, INCFXX2026-07-07
00840456214626JMUJMU DENTAL, INCFXX2026-07-07
00840456214633JMUJMU DENTAL, INCFXX2026-07-07
00840456214640JMUJMU DENTAL, INCFXX2026-07-07
00840456214657JMUJMU DENTAL, INCFXX2026-07-07
00850056441254Target Up&UpArmbrust Inc.FXX2026-06-25
16980077680262AOKAOK TOOLING LIMITEDFXX2026-06-24
16980077680255AOKAOK TOOLING LIMITEDFXX2026-06-22
00842942008894PRIMEDpriMED Medical Products IncFXX2026-06-21
06922820992584GraidRfx+Care Manufacturing Co., Ltd.FXX2026-06-09
16980077680217AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680224AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680231AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680248AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680170AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680187AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680194AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680200AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680149AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680156AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680163AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680101AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680118AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680125AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680132AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680071AOKAOK TOOLING LIMITEDFXX2026-05-28