FDA.report

EnviroSorb® CommodeShield™

Primary DI
00860010353288
Brand
EnviroSorb® CommodeShield™
Company
LDI Solutions, LLC
Model
ESCS-3524
Catalog number
ESCS-3524
Device description
EnviroSorb® CommodeShield™ 35 x 24, Extra Large 3-Ply Absorbent Commode Bag elastic draw string closure Packaged in bags of 5
Published
2025-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FOBBedpan

Product Code Classifications

CodeDeviceSpecialtyClass
FOBBedpanGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860010353288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010353288008600103532888600103532880860010353288

GMDN Terms

TermDefinition
Commode, manualA 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).

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature32 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
175311088
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00860010353271EnviroSorb® CommodeShield™ESCS-2824ESCS-28242025-03-04
00860010353264EnviroSorb® CommodeShield™ESCS-2424ESCS-24242025-03-03
00860010353202FlexGardCRG-SS-MTFCRG-MTF-SS2024-04-11
00860010353219FlexGardCRG-M-MTFCRG-MTF-MTF2024-04-11
00860010353226FlexGardCRG-SL-MTFCRG-SL-MTF2024-04-11
00860010353233FlexGardCRG-SXL-MTF2024-04-11
00860010353240FlexGardCRG-S2XL-MTF2024-04-11
00860010353257FlexGardCRG-S3XL-MTF2024-04-11

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