Device
V7ULB+-NA-1110
Manufacturer
Usine Rotec Inc
Model: V7ULB+-NA-1110 DI: 07540161720193 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-04-28 Current Version: 2026-05-06
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 058d3b43-62eb-44c8-bbff-f16ddeb56559
Distribution Status: In Commercial Distribution
DUNS Number: 245707815
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
Serial Number Tracked: Yes
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 07540161720193
Type: Primary
Issuing Agency: GS1
GMDN
Code: 34870
Name: Basic electric hospital bed
Definition:
A mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale.
FDA Product Codes
FNL
Bed, Ac-Powered Adjustable Hospital
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit: KiloPascal
Item #1 - Storage Handling Low - @attributes - Value: 70
Item #1 - Storage Handling High - @attributes - Unit: KiloPascal
Item #1 - Storage Handling High - @attributes - Value: 106
Item #1 - Storage Handling Type: Storage Environment Atmospheric Pressure
Item #2 - Storage Handling Low - @attributes - Unit: Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value: 10
Item #2 - Storage Handling High - @attributes - Unit: Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value: 100
Item #2 - Storage Handling Type: Storage Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit: Degrees Celsius
Item #3 - Storage Handling Low - @attributes - Value: -40
Item #3 - Storage Handling High - @attributes - Unit: Degrees Celsius
Item #3 - Storage Handling High - @attributes - Value: 70
Item #3 - Storage Handling Type: Storage Environment Temperature