FDA.reportPublic FDA data

ZD

Primary DI
06959385758317
Brand
ZD
Company
Zhende Medical Co., Ltd.
Model
/
Device description
Two-piece Ostomy Bag
Published
2023-07-05
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
PQEOstomy Care Kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06959385758317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06959385758317069593857583176959385758317

GMDN Terms#

Term, Definition table
TermDefinition
Intestinal ostomy bag/support kitA collection of devices intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure). It includes not only the intestinal ostomy bag and a base plate, but also additional ostomy fitting/maintenance supportive devices (e.g., towels, wipes, scissors). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
654591569
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
06959385787003ZDLYRC1200012023-06-22
06942273317574ZDNUMT0062024-01-22
06942273317598ZDNUMT0052024-01-22
06942273317611ZDNUMT0082024-01-22
06942273317635ZDNUMT0072024-01-22
06942273317659ZDNUMT0022024-01-22
06942273317673ZDNUMT0012024-01-22
06942273317697ZDNUMT0042024-01-22
06942273317710ZDNUMT0032024-01-22
06942273317734ZDNUMT0092024-01-22
06942273317758ZDNUMT0112024-01-22
06942273317772ZDNUMT0102024-01-22
06942273317796ZDNUMT0132024-01-22
06942273317819ZDNUMT0122024-01-22
06942273317833ZDNUMT0152024-01-22
06942273317857ZDNUMT0142024-01-22
06942273317871ZDNUMT0162024-01-22
06942273317895ZDNUMT016S2024-01-22
06942273317918ZDNUMT0172024-01-22
06942273317932ZDNUMT017S2024-01-22

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