FLEXI-SEAL

Primary DI
00768455117178
Brand
FLEXI-SEAL
Company
CONVATEC, PURCHASING DEPARTMENT
Model
418000
Device description
Flexi-Seal® Signal FMS Kit With 3 Bags With Charcoal Filter
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZQPOUCH, COLOSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZQPouch, ColostomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10768455117175PackageGS13In Commercial Distribution
00768455117178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845511717510768455117175
00768455117178007684551171787684551171780768455117178

GMDN Terms#

Term, Definition table
TermDefinition
Invasive faecal incontinence kitA collection of devices intended to be used for the conveyance and collection of stool (faeces) from the rectum to a collection bag for a patient who is unable to control stool discharge. It typically includes a (balloon) catheter, disposable collection bag, syringe, connectors, and ports for balloon inflation and irrigation and/or to deliver medication. The catheter is inserted into the rectum where it is retained for a prescribed length of time. The kit is appropriate for adult patients in an intensive care unit (ICU), other acute care settings, or for persons with a disability. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
809784593
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00768455145836FLEXI-SEAL4217032019-11-18
00768455157150FLEXI-SEAL4223032019-11-18
00768455185924FLEXI-SEAL4111082022-09-09
00768455209620FLEXI-SEAL4238542023-08-16
30768455143017FLEXI-SEAL4216304216302017-04-26
00768455108565FLEXI-SEAL4111004111002016-09-01
00768455109852FLEXI-SEAL4111004111002016-09-01
00768455143016FLEXI-SEAL4216302017-05-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950715504482cofoeCofoe Medical Technology Co.,LtdEZQ2024-12-09
06950715505588cofoeCofoe Medical Technology Co.,LtdEZQ2024-12-09
06950715505595cofoeCofoe Medical Technology Co.,LtdEZQ2024-12-09
06950715505601cofoeCofoe Medical Technology Co.,LtdEZQ2024-12-09
00768455204250ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
00768455204267ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
00768455204274ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
00768455204380ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
00768455204397ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
00768455204403ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204257ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204264ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204271ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204387ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204394ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204400ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
00768455114658ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTEZQ2022-10-14
00768455207114FLEXI-SEALCONVATEC, PURCHASING DEPARTMENTEZQ2022-10-14
10768455114655ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTEZQ2022-10-14
00768455157174FLEXI-SEALCONVATEC, PURCHASING DEPARTMENTEZQ2022-10-14
10768455169716ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-30
10768455169723ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-30
10768455169730ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-30
10768455169747ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-30
10768455169754ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-30
00768455102549ACTIVELIFECONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
00768455111770ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
00768455111794ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
00768455111800ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
00768455111824ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29