FDA.report

FLEXI-SEAL FMS KIT

Primary DI
00768455108565
Brand
FLEXI-SEAL FMS KIT
Company
CONVATEC, PURCHASING DEPARTMENT
Model
411100
Catalog number
411100
Device description
FLEXI-SEAL FMS KIT
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

Product Codes

CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10768455108562PackageGS13In Commercial Distribution
00768455108565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510856210768455108562
00768455108565007684551085657684551085650768455108565

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

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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