FDA.reportPublic FDA data

EnviroCare Pouch

Primary DI
00199284374782
Brand
EnviroCare Pouch
Company
EnviroCare Health Limited Liability Company
Model
1
Device description
This environmentally sustainable toileting system, which replaces the traditional commode bucket, will provide a safe disposable system for human waste while reducing infection rates.
Published
2025-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
00199284374782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199284374782001992843747821992843747820199284374782

GMDN Terms#

Term, Definition table
TermDefinition
Bedpan linerA device intended to be fitted into and line a bedpan, or related device, to collect waste during use and thereby function as a disposable physical barrier to reduce/prevent cross-contamination between patients using the bedpan. It is typically designed as a shaped bowl-like container with a rim made of disposable materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
133512636
Device count
1
Premarket exempt
true

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
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
00860010353288EnviroSorb® 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