cofoe

Primary DI
06950715505656
Brand
cofoe
Company
Cofoe Medical Technology Co.,Ltd
Model
R4
Device description
Ostomy Barrier Ring
Published
2024-12-09
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
EZRCement, Stomal Appliance, Ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZRCement, Stomal Appliance, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06950715505656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950715505656069507155056566950715505656

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
544425204
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06950715563090CofoeZBC242026-02-24
06950715500002COFOEZA-012022-01-10
06950715500019COFOEDM3792022-01-10
06950715500026COFOECC3302022-01-10
06950715500033COFOERC3302022-01-10
06950715500040COFOESPTT3302022-01-10
06950715500057COFOEPTT3302022-01-10
06950715500064COFOESPTT9202022-01-10
06950715500071COFOEPTT9202022-01-10
06950715500088COFOECC9202022-01-10
06950715500095COFOEICS920-B2022-01-10
06950715500101COFOEF3002022-01-10
06950715500118COFOEICS300-B2022-01-10
06950715500125COFOECC102022-01-10
06950715500132COFOECN9202022-01-10
06950715500149COFOEICS3302022-01-10
06950715501665CofoeKF-GDD-F012024-07-04
06950715501672CofoeKF-GDD-F022024-07-04
06950715501689CofoeKF-GDD-F032024-07-04
06950715501696CofoeKF-GDD-F042024-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950715505984cofoeCofoe Medical Technology Co.,LtdEZR2025-02-18
06950715505649cofoeCofoe Medical Technology Co.,LtdEZR2024-12-09
06950715505663cofoeCofoe Medical Technology Co.,LtdEZR2024-12-09
06950715505670cofoeCofoe Medical Technology Co.,LtdEZR2024-12-09
06948909454729BynexShaoxing Haoshide Medical Products Co., Ltd.EZR2024-08-22
06948909454736BynexShaoxing Haoshide Medical Products Co., Ltd.EZR2024-08-22
06948909454705BynexShaoxing Haoshide Medical Products Co., Ltd.EZR2024-08-21
06948909454712BynexShaoxing Haoshide Medical Products Co., Ltd.EZR2024-08-21
00610075205479AdaptHOLLISTER INCORPORATEDEZR2022-12-01
00610075793013AdaptHOLLISTER INCORPORATEDEZR2022-12-01
00610075079100Karaya 5HOLLISTER INCORPORATEDEZR2022-12-01
00610075084166SecuriTHOLLISTER INCORPORATEDEZR2022-12-01
10610075068057SecuriTHOLLISTER INCORPORATEDEZR2022-12-01
20610075079104Karaya 5HOLLISTER INCORPORATEDEZR2022-12-01
10610075084163SecuriTHOLLISTER INCORPORATEDEZR2022-12-01
20610075205473AdaptHOLLISTER INCORPORATEDEZR2022-12-01
10610075793010AdaptHOLLISTER INCORPORATEDEZR2022-12-01
20610075068054SecuriTHOLLISTER INCORPORATEDEZR2022-12-01
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00612479227279McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2018-11-09