FDA.reportPublic FDA data

Bynex

Primary DI
06948909401310
Brand
Bynex
Company
Shaoxing Haoshide Medical Products Co., Ltd.
Model
22055
Device description
Two-piece ostomy bag Flat Wafer 10 pieces/box 15boxes/carton
Published
2023-06-28
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
PQEOstomy Care Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQEOstomy Care KitGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948909453722PackageGS115In Commercial Distribution
06948909401310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948909453722069489094537226948909453722
06948909401310069489094013106948909401310

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
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
00610075099443CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099450CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099474CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099481CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099498CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099504CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099511CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099528CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099603CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099610CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099627CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099440CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099457CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099471CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099488CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099495CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099501CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099518CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099525CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099600CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099617CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099624CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075098514New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098521New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098538New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098545New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098569New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098576New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075095735HollisterHOLLISTER INCORPORATEDPQE2024-10-01
00610075095742HollisterHOLLISTER INCORPORATEDPQE2024-10-01