DEVICE: Bard® DigniShield® Stool Management System Collection Bags (00801741045967)
Device Identifier (DI) Information
Bard® DigniShield® Stool Management System Collection Bags
SMS2B1L
In Commercial Distribution
SMS2B1L
C. R. Bard, Inc.
SMS2B1L
In Commercial Distribution
SMS2B1L
C. R. Bard, Inc.
Bard® DigniShield® Stool Management System Collection Bags
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47038 | Faecal incontinence collector, catheterization |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e0748ee8-acdc-48e8-9dea-e9d61c0e04b4
December 21, 2020
3
August 25, 2016
December 21, 2020
3
August 25, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10801741045964 | 10 | 00801741045967 | In Commercial Distribution | CA |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)526-4455
medical.services@crbard.com
medical.services@crbard.com