Identity
- Trade Name
- Mor-Medical New Era FDA UDI
- Generic Name
- Commode, manual FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- DNE-310-3TWL-DDA FDA UDI
- 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850010988085 FDA UDI
- FDA Product Code
- INM FDA UDI
- GMDN Term
- Commode, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Commode, manual
Mor-Medical New Era by Moroles Investments, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Commode, manual.
- Drive — Drive Devilbiss Healthcare · Class I
- Shower Commode 30 — SIZEWISE RENTALS, L.L.C. · Class I
- Giloga — Zhongshan Jiale Rehabilitation Medical Equipment Co., Ltd · Class I
- DRIVE — Drive Devilbiss Healthcare · Class I
- Etac Supply Center AB — Etac Supply Center AB · Class I
- Drive — Drive Devilbiss Healthcare · Class I
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
- Drive — Drive Devilbiss Healthcare · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Moroles Investments, LLC
Sources (1)
- FDA UDI 2dba0329-7226-4bc2-8aee-4c8c46b5a043 33 fields · synced May 31, 2026