FDA.report

FLEXI-SEAL SIGNAL FMS RX ZEOLITE

Primary DI
00768455117178
Brand
FLEXI-SEAL SIGNAL FMS RX ZEOLITE
Company
CONVATEC, PURCHASING DEPARTMENT
Model
418000
Catalog number
418000
Device description
FLEXI-SEAL SIGNAL FMS RX ZEOLITE
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EZQPOUCH, COLOSTOMY
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
EZQPouch, ColostomyGastroenterology, Urology1
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10768455117175PackageGS13In Commercial Distribution
00768455117178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845511717510768455117175
00768455117178007684551171787684551171780768455117178

GMDN Terms

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

Contacts

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
false
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 DIBrandModelCatalogPublished
10768455203946ESTEEM4236452024-09-13
10768455209481ESENTA4238272024-08-26
10768455209511ESENTA4238262024-08-26
00768455204793GENTLECATH5106002024-04-05
00768455204823GENTLECATH5106012024-04-05
00768455204854GENTLECATH5106022024-04-05
00768455207145GENTLECATH5106032024-04-05
00768455207169GENTLECATH5106042024-04-05
00768455207206GENTLECATH5106052024-04-05
10815947021172CURE PRODUCTSHM16UK2024-03-30
10768455203922ESTEEM4236432024-03-20
10768455203939ESTEEM4236442024-03-20
10768455203953ESTEEM4236462024-03-20
10768455203960ESTEEM4236472024-03-20
10768455203977ESTEEM4236482024-03-20
10768455204004ESTEEM4236512024-03-20
10768455204011ESTEEM4236522024-03-20
10768455204028ESTEEM4236532024-03-20
10768455204035ESTEEM4236542024-03-20
10768455204059ESTEEM4236562024-03-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50192253068762CARDINAL HEALTHCardinal Health 200, LLCKNT2026-02-25
50192253068779CARDINAL HEALTHCardinal Health 200, LLCKNT2026-02-25
50192253068809CARDINAL HEALTHCardinal Health 200, LLCKNT2026-02-25
00842071146412MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-02-13
00842071146429MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-02-13
00816340023162Transfer StrawNEODEVICES INCKNT2026-02-05
20885632464475HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-30
20197344200358MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20197344200365MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20197344200372MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20197344200389MEDLINEMEDLINE INDUSTRIES, INC.KNT2026-01-27
20885632465069HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465076HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465083HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465106HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465113HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465120HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465137HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465144HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465175HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465281HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465335HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465342HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465380HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465434HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465465HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632465489HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-23
20885632464642HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-22
20885632464659HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-22
20885632464802HalyardOWENS & MINOR DISTRIBUTION, INC.KNT2026-01-22