DEVICE: EnviroSorb® CommodeShield™ (00860010353264)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
EnviroSorb® CommodeShield™
ESCS-2424
In Commercial Distribution
ESCS-2424
LDI Solutions, LLC
00860010353264
GS1

1
175311088 *Terms of Use
EnviroSorb® CommodeShield™ 24 x 24, 3-Ply Absorbent Commode Bag elastic draw string closure Packaged in bags of 5
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
40539 Commode, manual
A non-active, manually-operated transportable device in the form of a chair with a receptacle for collecting urine and faeces intended to enable a patient with a disability to urinate/defecate away from a bathroom or fixed toilet (e.g., in the bedroom); it may additionally be used to assist with sitting on the toilet or washing in a shower or bath, however it is not a dedicated toilet seat or shower seat. Also known as a sanichair, it may incorporate hydraulically-assisted seat height and/or tilt adjustment, and/or wheels (castors).
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FOB Bedpan
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 32 and 120 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
9a65d3c3-1190-45d1-84e0-44a233cabb8f
March 11, 2025
1
March 03, 2025
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
16034360077
customerservice@LDImedical.com
CLOSE