FDA.reportPublic FDA data

MDK-MEDICAL

Primary DI
06974795055948
Brand
MDK-MEDICAL
Company
Henan Maidingkang Medical Technology Co., Ltd.
Model
29*14.2cm
Published
2025-04-23
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
EXGBag, Urine Collecting, Ureterostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXGBag, Urine Collecting, UreterostomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974795055948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974795055948069747950559486974795055948

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
724981491
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974795059366MEDLOT5×12.5cm2026-10-29
06974795059106MEDLOT44*69mm+37*55mm+42*45mm+41*62mm+21*65mm+18*61mm+202026-05-06
06974795059540MEDLOT44*69mm+37*55mm+42*45mm+41*62mm+21*65mm+18*61mm+202026-05-06
06974795053920MEDLOT10*10cm2026-03-13
06974795054392MEDLOT5cm*4.88m2026-01-06
06974795059120MEDLOT10*10cm2025-10-09
06974795053142MEDLOT15*15cm2025-09-29
06974795055474MEDLOT15*15cm2025-09-29
06974795056341MEDLOT5cm*4.88m2025-08-22
06974795057256MEDLOT5cm*3.66m2025-08-22
06974795058314MEDLOT5cm*3.66m2025-08-22
06974795051940MEDLOT4cm*2m2025-08-13
06974795055580MEDLOT4cm*2m2025-08-13
06974795059861MEDLOT4cm*4m2025-08-13
06974795057119MEDLOT10*10cm2025-08-04
06974795058864MEDLOT10*10cm2025-08-04
06974795056150MEDLOT15*15cm2025-08-01
06974795053371MEDLOT10*18cm2025-07-29
06974795057508MEDLOT4*15cm2025-07-29
06974795056242MEDLOT4*15cm2025-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970944382392OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-31
06970944382583OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-30
06970944382415OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-27
06970944383740OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-27
06970944383757OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-09
06974795058116MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXG2025-04-23
06974795059199MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXG2025-04-23
00810040135170Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135187Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135248Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135255Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135293Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135309Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135163Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135231Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135286Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
06974567745886EMSRUNWuxi Emsrun Technology Co., Ltd.EXG2024-05-22
16974567745883EMSRUNWuxi Emsrun Technology Co., Ltd.EXG2024-05-22
10768455204530ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204547ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204615ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204622ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204639ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204646ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204653ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204660ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204677ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204714ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204721ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204745ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20