FLEXI-SEAL

Primary DI
00768455125722
Brand
FLEXI-SEAL
Company
CONVATEC, PURCHASING DEPARTMENT
Model
411108
Catalog number
411108
Device description
Flexi-Seal® Privacy Bag
Published
2022-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00768455125722PackageGS110In Commercial Distribution
10768455125729PackageGS16In Commercial Distribution
00768455185924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00768455125722007684551257227684551257220768455125722
1076845512572910768455125729
00768455185924007684551859247684551859240768455185924

GMDN Terms#

Term, Definition table
TermDefinition
Faecal incontinence kitA collection of devices used for the conveyance and collection of liquid/semi-liquid 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, a disposable collection bag, a syringe, connectors, and ports for balloon inflation and irrigation. The catheter is inserted into the rectum where it is retained by the inflatable balloon 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-422-8811cic@convatec.com
+18004228811cic@convatec.com

Regulatory Flags#

DUNS number
809784593
Device count
1
DM exempt
false
Premarket exempt
true
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
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
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