FDA UDI
In Commercial Distribution
🇺🇸 United States
Mor-Medical New Era
DI: 00850010988085
·
Model: DNE-310-3TWL-DDA
·
Moroles Investments, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mor-Medical New Era
- Primary DI
- 00850010988085
- Version / Model
- DNE-310-3TWL-DDA
- Company Name
- Moroles Investments, LLC
- Labeler DUNS
- 045103307
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-16
- Public Version
- 2
- Public Version Date
- 2024-10-21
- Public Version Status
- Update
- Public Device Record Key
- 2dba0329-7226-4bc2-8aee-4c8c46b5a043
Device Description
Deluxe New Era Patented Infection Control 22" Shower Commode Chair, with Open Front Soft Seat and Insert, Double Drop Arms, Slide Out Commode Pail, 3" All Locking Casters, 310 lbs. wt. capacity
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| INM | Chair, With Casters | Physical Medicine | 890.3100 | 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 | 00850010988085 | GS1 |