FDA.reportPublic FDA data

Bard® DigniShield® Stool Management System Collection Bags

Primary DI
00801741045967
Brand
Bard® DigniShield® Stool Management System Collection Bags
Company
C. R. Bard, Inc.
Model
SMS2B1L
Catalog number
SMS2B1L
Device description
Bard® DigniShield® Stool Management System Collection Bags
Published
2016-08-25
Public version status
Update
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
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
10801741045964PackageGS110In Commercial Distribution
00801741045967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174104596410801741045964
00801741045967008017410459678017410459670801741045967

GMDN Terms#

Term, Definition table
TermDefinition
Faecal incontinence collector, 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.

Contacts#

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

Regulatory Flags#

DUNS number
016898496
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741236563SURESTEPSSPEDINTS08SSPEDINTS082026-10-06
00801741236570SURESTEPSSPEDINTS10SSPEDINTS102026-10-06
00801741236587SURESTEPSSINTL15SSINTL152026-10-06
00801741236594SURESTEPSSINTL16CSSINTL16C2026-10-06
00801741236600SURESTEPSSINTS14SSINTS142026-10-06
00801741236617SURESTEPSSINTS14CSSINTS14C2026-10-06
00801741236624SURESTEPSSINTS16SSINTS162026-10-06
00801741236631SURESTEPSSINTS16CSSINTS16C2026-10-06
00801741045943Bard® DigniShield® Stool Management SystemSMS002SMS0022016-08-25
00801741050930Fecal Containment Device1900111900112020-09-22
00801741113147Bard® DigniShield® Stool Management System with ENFit™ENSMS002ENSMS0022016-11-03
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

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