FDA.reportPublic FDA data

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
Single use
true

Product Codes#

Code, Name table
CodeName
FOBBedpan

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOBBedpanGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010353288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010353288008600103532888600103532880860010353288

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature32 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
175311088
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00661392005860LSL HEALTHCARELSL Industries, LLCFOB2025-10-30
00661392011960LSL HEALTHCARELSL Industries, LLCFOB2025-10-30
00661392012301LSL HEALTHCARELSL Industries, LLCFOB2025-10-30
00661392012622LSL HEALTHCARELSL Industries, LLCFOB2025-10-30
00194613096496MSI Precision Specialty InstrumentsMed Saver, Inc.FOB2025-08-01
00199284374782EnviroCare PouchEnviroCare Health Limited Liability CompanyFOB2025-06-30
00661392011953LSL HEALTHCARELSL Industries, LLCFOB2025-05-16
00661392012585LSL HEALTHCARELSL Industries, LLCFOB2025-05-16
10661392011950LSL HEALTHCARELSL Industries, LLCFOB2025-05-16
10661392012582LSL HEALTHCARELSL Industries, LLCFOB2025-05-16
00860010353271EnviroSorb® CommodeShield™LDI Solutions, LLCFOB2025-03-04
00860010353264EnviroSorb® CommodeShield™LDI Solutions, LLCFOB2025-03-03
00818323021752ViveVIVE HEALTH LLCFOB2024-01-12
00818323026702ViveVIVE HEALTH LLCFOB2024-01-12
00818323026719ViveVIVE HEALTH LLCFOB2024-01-12
10818323021759ViveVIVE HEALTH LLCFOB2024-01-12
10818323026709ViveVIVE HEALTH LLCFOB2024-01-12
10818323026716ViveVIVE HEALTH LLCFOB2024-01-12
00810041989444ViveVIVE HEALTH LLCFOB2023-11-13
00810041989727ViveVIVE HEALTH LLCFOB2023-11-13
00810113574639ViveVIVE HEALTH LLCFOB2023-11-13
00810113574646ViveVIVE HEALTH LLCFOB2023-11-13
00810113574653ViveVIVE HEALTH LLCFOB2023-11-13
00810113574660ViveVIVE HEALTH LLCFOB2023-11-13
00810113574783ViveVIVE HEALTH LLCFOB2023-11-13
00810113574790ViveVIVE HEALTH LLCFOB2023-11-13
10810041989441ViveVIVE HEALTH LLCFOB2023-11-13
10810041989724ViveVIVE HEALTH LLCFOB2023-11-13
10810113574636ViveVIVE HEALTH LLCFOB2023-11-13
10810113574643ViveVIVE HEALTH LLCFOB2023-11-13