FDA.reportPublic FDA data

FLEXI-SEAL

Primary DI
00768455209620
Brand
FLEXI-SEAL
Company
CONVATEC, PURCHASING DEPARTMENT
Model
423854
Device description
Flexi-Seal Protect FMS with Enfit
Published
2023-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTubes, gastrointestinal (and accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10768455209627PackageGS13In Commercial Distribution
00768455209620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845520962710768455209627
00768455209620007684552096207684552096200768455209620

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
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
00768455101481ACTIVELIFE0227582018-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00350770005881CORTRAK* 2 Enteral Access SystemAvanos Medical, Inc.KNT2026-09-30
00350770007915CORTRAK* 2 Enteral Access SystemAvanos Medical, Inc.KNT2026-09-30
00842071146290MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146306MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146313MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146320MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146351MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146368MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146399MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146405MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146450MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146467MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146511MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146528MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146559MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146566MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146597MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
00842071146603MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-09-29
G461CEGCT40M0EndolumikEndolumik, Inc.KNT2026-08-25
00350770006840CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770009094CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770007557CORFLO* Safety PEG KitAvanos Medical, Inc.KNT2026-08-14
00842071146436MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071146443MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071153083NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153106NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153120NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00816340021632EL-SPIKE-MNEODEVICES INCKNT2026-06-01