FDA.reportPublic FDA data

Maytex Ultra Safety

Primary DI
D8063135B1
Brand
Maytex Ultra Safety
Company
MAYTEX CORPORATION
Model
3135B
Device description
Level 3 ear loop mask
Published
2019-07-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
D8063135B1PrimaryHIBCC0
D8063135B0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical respirator, 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., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) during medical, surgical, dental, and isolation procedures. It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196642151
Device count
50
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8063145BL1Cool Breathe3145BL2024-06-11
D8066050B1Maytex6050B2024-06-11
D8063145BL0Cool Breathe3145BL2024-06-11
D8066050B0Maytex6050B2024-06-11
D806OSI5324132MIZUHO OSI OSI5324-132016-09-23
D806OSI581212MIZUHO OSI OSI5812-12016-09-23
D806OSI5817122MIZUHO OSIOSI5817-122016-09-23
D806OSI5844112MIZUHO OSI OSI5844-112016-09-23
D806OSI5844122MIZUHO OSI OSI5844-122016-09-23
D806OSI94112MIZUHO OSIOSI941-12016-09-23
D8066050BXL1Maytex6050BXL2024-06-10
D8066250TL1Maytex6250T-L2024-06-10
D8066250TM1Maytex6250T-M2024-06-10
D8066250TS1Maytex6250T-S2024-06-10
D8066250TXL1Maytex6250T-XL2024-06-10
D8066050BXL0Maytex6050BXL2024-06-10
D8066250TL0Maytex6250T-L2024-06-10
D8066250TM0Maytex6250T-M2024-06-10
D8066250TS0Maytex6250T-S2024-06-10
D8066250TXL0Maytex6250T-XL2024-06-10

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
00850056441261Target Up&UpArmbrust Inc.FXX2026-06-25
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