FDA.reportPublic FDA data

Bynex

Primary DI
06948909401280
Brand
Bynex
Company
Shaoxing Haoshide Medical Products Co., Ltd.
Model
3005
Device description
Ostomy Care Accessories 10 pieces/box 30 boxes/carton
Published
2024-03-01
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
EXEProtector, Ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXEProtector, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948909453692PackageGS130In Commercial Distribution
06948909401280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948909453692069489094536926948909453692
06948909401280069489094012806948909401280

GMDN Terms#

Term, Definition table
TermDefinition
Peristomal/periwound dressingA non-sterile substance or material intended to be applied to peristomal and/or periwound skin intended to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the seal of a stomal appliance or wound dressing. The device is typically available in a variety of forms including cream, paste in a tube or other applicator, paste in ready formed strips, or powder. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420764429
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06948909456020N/AP169C1BK2024-11-25
06948909456044N/AP169C2BK2024-11-25
06948909456068N/AP169C3BK2024-11-25
06948909456082N/AP169C4BK2024-11-25
06948909456105N/AP169C5BK2024-11-25
06948909456129N/AP169C6BK2024-11-25
06948909456143N/AP169C20BK2024-11-25
06948909456181N/AP169C22BK2024-11-25
06948909456204N/AP169C23BK2024-11-25
06948909456228N/AP169C24BK2024-11-25
06948909456242N/AP169C15BK2024-11-25
06948909456280N/AP169C17BK2024-11-25
06948909456303N/AP169C18BK2024-11-25
06948909456327N/AP169C19BK2024-11-25
06948909456341N/AP169C25BK2024-11-25
06948909456365N/AP169C26BK2024-11-25
06948909456389N/AP169C27BK2024-11-25
06948909456402N/AP169C28BK2024-11-25
06948909456426N/AP169C29BK2024-11-25
06948909456440N/AP169C32BK2024-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00610075099122CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
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00610075099146CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099153CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099160CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00810178887132ViveVIVE HEALTH LLCEXE2026-05-05
00810178887149ViveVIVE HEALTH LLCEXE2026-05-05
00610075097142AdaptHOLLISTER INCORPORATEDEXE2026-03-13
00610075097159AdaptHOLLISTER INCORPORATEDEXE2026-03-13
00610075097166AdaptHOLLISTER INCORPORATEDEXE2026-03-13
15056276805513EakinT.G. EAKIN LIMITEDEXE2026-02-03
15056276819060EakinT.G. EAKIN LIMITEDEXE2026-02-03
15056276819084EakinT.G. EAKIN LIMITEDEXE2026-02-03
15056276819091EakinT.G. EAKIN LIMITEDEXE2026-02-03
00610075097173CeraPlusHOLLISTER INCORPORATEDEXE2026-01-15
00610075097180CeraPlusHOLLISTER INCORPORATEDEXE2026-01-15
00610075097203AdaptHOLLISTER INCORPORATEDEXE2026-01-15
00610075097210AdaptHOLLISTER INCORPORATEDEXE2026-01-15
00610075097227AdaptHOLLISTER INCORPORATEDEXE2026-01-15
00810113576992ViveCareVIVE HEALTH LLCEXE2025-05-13
00810113577098ViveCareVIVE HEALTH LLCEXE2024-09-04
00810113577135ViveCareVIVE HEALTH LLCEXE2024-09-04
00810113577159ViveCareVIVE HEALTH LLCEXE2024-09-04
00768455209484ESENTACONVATEC, PURCHASING DEPARTMENTEXE2024-08-26
00768455209514ESENTACONVATEC, PURCHASING DEPARTMENTEXE2024-08-26
00810113577142ViveCareVIVE HEALTH LLCEXE2024-07-12
00610075094752AdaptHOLLISTER INCORPORATEDEXE2024-01-16
00768455108725EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455108732EakinT.G. EAKIN LIMITEDEXE2023-05-16