Model: MDR3E
Catalog: MDR3E
DI: 10197344215461
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
BASIC FULL-E BED
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
67e43e21-aa1a-4b3b-af92-246c5eafdf47
Distribution Status:
In Commercial Distribution
DUNS Number:
025460908
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
10197344215461
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46365
Name: Basic electric home bed
Definition:
A mains electricity (AC-powered) motorized bed designed to be used in the home by a patient for rest/sleep, and that provides the occupant with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard and a remote control to operate the electrical motors. The device typically raises the torso and/or legs to various heights. It may also include a heatable mattress and physical therapy pulsators.
FDA Product Codes
LLI
Bed, therapeutic, ac-powered, adjustable home-use