FDA.reportPublic FDA data

Maytex

Primary DI
D8066050B1
Brand
Maytex
Company
MAYTEX CORPORATION
Model
6050B
Device description
Barrier Gown Blue
Published
2024-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8066050B1PrimaryHIBCC0
D8066050B0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Regulatory Flags#

DUNS number
196642151
Device count
50
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8063145BL1Cool Breathe3145BL2024-06-11
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
D8063135BL1Maytex 3135BL2022-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30193489104893MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489107969MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120241MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120258MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50080196247576MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50193489109885MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50193489109892MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40884389804637MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-17
50193489108239MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-17
40080196772026MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-03
00199536901001BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901018BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901308BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901315BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901407BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901414BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901421BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901438BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901445BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901452BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901469BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901476BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00842942017506PRIMED / CaracalpriMED Medical Products IncOEA2025-11-26
00842942017513PRIMED / CaracalpriMED Medical Products IncOEA2025-11-26
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
00842942016530PRIMEDpriMED Medical Products IncOEA2025-07-21
00842942015700PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942015717PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942017261PRIMEDpriMED Medical Products IncOEA2025-07-17