FDA.reportPublic FDA data

Bard® DigniShield® Stool Management System Collection Bags

Primary DI
10801741045964
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
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
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 collection bag, 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
016898496
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
true
Sterilization required before use
false

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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