FDA UDI
In Commercial Distribution
🇺🇸 United States
EnviroCare Pouch
DI: 00199284374782
·
Model: 1
·
EnviroCare Health Limited Liability Company
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EnviroCare Pouch
- Primary DI
- 00199284374782
- Version / Model
- 1
- Company Name
- EnviroCare Health Limited Liability Company
- Labeler DUNS
- 133512636
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-30
- Public Version
- 1
- Public Version Date
- 2025-07-08
- Public Version Status
- New
- Public Device Record Key
- f78dec95-8642-4645-92ec-9a61e314eb97
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 10335 | Bedpan liner | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00199284374782 | GS1 |