FDA.reportPublic FDA data

Fecal Containment Device

Primary DI
00801741050930
Brand
Fecal Containment Device
Company
C. R. Bard, Inc.
Model
190011
Catalog number
190011
Device description
FCD Fecal Containment Device
Published
2020-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXBCOLLECTOR, OSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXBCollector, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741050937PackageGS125In Commercial Distribution
00801741050930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174105093710801741050937
00801741050930008017410509308017410509300801741050930

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags#

DUNS number
016898496
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741050817Leg Bag1505071505072020-09-23
00801741076039Catheter Stabilization DeviceVFDSPVFDSP2020-09-22
00801741076053Catheter Stabilization DeviceVFDSSPVFDSSP2020-09-22
00801741076077Catheter Stabilization DeviceFOL0100FOL01002020-09-22
00801741076091Catheter Stabilization DeviceFOL0101FOL01012020-09-22
00801741076114Catheter Stabilization DeviceFOL0102FOL01022020-09-22
00801741076145Catheter Stabilization DeviceFOL0105FOL01052020-09-22
00801741127625Bard® Leg Bag Holders1501111501112016-08-10
00801741127632Bard® Leg Bag Holders1501211501212016-08-10
00801741127649Bard® Leg Bag Holders1501311501312016-08-10
00801741137419Bard® Wide Leg Bag Straps1621101621102018-02-06
00801741137426Bard® Wide Leg Bag Straps1622101622102018-02-06
00801741137433Bard® Wide Leg Bag Straps1623101623102018-02-06
00801741215902StatLock UrologicalSTATURO25STATURO252020-10-23
00801741231025PureWickPW300PCPW300PC2026-05-07
00801741234514PureWickPWA300HPWA300H2026-05-07
00801741225239Elyra708200170820012026-05-06
00801741225246Elyra708200270820022026-05-06
00801741231537PureWickPWKIT03HPWKIT03H2026-05-06
10801741239219PureWickPWF030KXSPWF030KXS2026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09421905447225The Insides NeoTHE INSIDES COMPANY LIMITEDEXB2025-10-16
00610075095728New ImageHOLLISTER INCORPORATEDEXB2024-12-19
09421905447195The Insides NeoTHE INSIDES COMPANY LIMITEDEXB2023-05-26
00610075090266PremierHOLLISTER INCORPORATEDEXB2023-02-13
00610075090273PremierHOLLISTER INCORPORATEDEXB2023-02-13
00610075090280PremierHOLLISTER INCORPORATEDEXB2023-02-13
10610075077158m9HOLLISTER INCORPORATEDEXB2022-12-01
10610075077172m9HOLLISTER INCORPORATEDEXB2022-12-01
10610075077325m9HOLLISTER INCORPORATEDEXB2022-12-01
10610075077332m9HOLLISTER INCORPORATEDEXB2022-12-01
10610075077349m9HOLLISTER INCORPORATEDEXB2022-12-01
10610075077356m9HOLLISTER INCORPORATEDEXB2022-12-01
10610075077363m9HOLLISTER INCORPORATEDEXB2022-12-01
10610075114747New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029839New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029846New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029853New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029860New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029877New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029884New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029891New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029907New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029914New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029921New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075031849HollisterHOLLISTER INCORPORATEDEXB2022-12-01
00610075031863HollisterHOLLISTER INCORPORATEDEXB2022-12-01
00610075033263Karaya 5HOLLISTER INCORPORATEDEXB2022-12-01
00610075037742PouchkinsHOLLISTER INCORPORATEDEXB2022-12-01
00610075051762New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051779New ImageHOLLISTER INCORPORATEDEXB2022-12-01