FDA.reportPublic FDA data

ACTIVELIFE

Primary DI
00768455106646
Brand
ACTIVELIFE
Company
CONVATEC, PURCHASING DEPARTMENT
Model
650831
Device description
"Activelife® One-Piece Urostomy Pouch With Durahesive® Skin Barrier, & Accuseal® Tap, W/1 Sided Comfort Panel, Trans, 1 1/8"" (28 Mm.)"
Published
2022-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXHBAG, URINARY, ILEOSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXHBag, Urinary, IleostomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10768455106643PackageGS120In Commercial Distribution
00768455106646PrimaryGS10
00768455190256Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510664310768455106643
00768455106646007684551066467684551066460768455106646
00768455190256007684551902567684551902560768455190256

GMDN Terms#

Term, Definition table
TermDefinition
One-piece intestinal ostomy bag, open-endedA plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of in accordance with the clinician's instructions. The distal end of the pouch can be opened for drainage of the waste (average of 400-800 ml per day) and emptied several times per day. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+18004228811cic@convatec.com

Regulatory Flags#

DUNS number
809784593
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00768455201303AVELLE4466504466502023-02-22
00768455108268STOMAHESIVE0255102022-09-28
00768455101399ACTIVELIFE0209222018-11-09
00768455101405ACTIVELIFE0227502018-11-09
00768455101412ACTIVELIFE0227512018-11-09
00768455101429ACTIVELIFE0227522018-11-09
00768455101436ACTIVELIFE0227532018-11-09
00768455101443ACTIVELIFE227542018-11-09
00768455101450ACTIVELIFE0227552018-11-09
00768455101467ACTIVELIFE0227562018-11-09
00768455101474ACTIVELIFE0227572018-11-09
00768455101481ACTIVELIFE0227582018-11-09
00768455101498ACTIVELIFE0227592018-11-09
00768455101504ACTIVELIFE0227602018-11-09
00768455101511ACTIVELIFE0227612018-11-09
00768455101528ACTIVELIFE0227622018-11-16
00768455101535ACTIVELIFE0227632018-11-16
00768455101542ACTIVELIFE0227642018-11-16
00768455101559ACTIVELIFE0227652018-11-16
00768455101566ACTIVELIFE0227662018-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974795051810MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795051896MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795053777MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795054101MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795054736MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795055504MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795056174MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795058390MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795058581MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795059632MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
00768455204533ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204540ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204618ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204625ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204632ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204649ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204656ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204663ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204670ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204717ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204724ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204748ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204755ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204762ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204530ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204547ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204615ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204622ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204639ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204646ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20