FLEXI-SEAL FMS

Primary DI
10768455107909
Brand
FLEXI-SEAL FMS
Company
CONVATEC, PURCHASING DEPARTMENT
Model
411101
Device description
Flexi-Seal FMS Collection Bags
Published
2019-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10768455107909PackageGS16In Commercial Distribution
00768455107902PrimaryGS10
80768455107908Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510790910768455107909
00768455107902007684551079027684551079020768455107902
8076845510790880768455107908

GMDN Terms#

Term, Definition table
TermDefinition
Faecal incontinence collection bag, catheterizationA receptacle intended to be used for the collection of liquid or semi-liquid stool (faeces) from a patient who is unable to control stool discharge. It consists of a faecal collection bag/pouch, a dedicated catheter intended to be attached to the bag proximally and inserted into the rectum distally, and adaptors/connectors. It is made of soft plastic material and may also include a drainage port and a syringe to drain faecal matter and/or to deliver medication. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
809784593
Device count
10
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
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
00768455117178FLEXI-SEAL4180002016-09-01
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

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