FDA UDI
In Commercial Distribution
🇺🇸 United States
EnviroSorb® CommodeShield™
DI: 00860010353288
·
Model: ESCS-3524
·
LDI Solutions, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EnviroSorb® CommodeShield™
- Primary DI
- 00860010353288
- Version / Model
- ESCS-3524
- Catalog Number
- ESCS-3524
- Company Name
- LDI Solutions, LLC
- Labeler DUNS
- 175311088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-04
- Public Version
- 1
- Public Version Date
- 2025-03-12
- Public Version Status
- New
- Public Device Record Key
- 8b62ac9f-a08d-40d0-a27c-2b6e42f3be87
Device Description
EnviroSorb® CommodeShield™ 35 x 24, Extra Large 3-Ply Absorbent Commode Bag elastic draw string closure Packaged in bags of 5
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FOB | Bedpan | General Hospital | 880.6730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860010353288 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 120 Degrees Fahrenheit