FDA.report

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

Related Records

Contact Domains

Product Codes

CodeName
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741045964PackageGS110In Commercial Distribution
00801741045967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174104596410801741045964
00801741045967008017410459678017410459670801741045967

GMDN Terms

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

Contacts

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

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