AccessGUDID - DEVICE: Freedom 500 (00670482000081)

GUDID

Device Identifier (DI) Information

Brand Name: Freedom 500
Version or Model: FM500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FM500
Company Name: Umano Medical Inc

Primary DI Number: 00670482000081
Issuing Agency: GS1
Commercial Distribution End Date: January 09, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 249675476 *Terms of Use

Device Description: The Freedom500 is an AC-powered medical bed with 4 built-in electric DC actuators. The height and surface contours are adjustable.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34870	Basic electric hospital bed	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNL	Bed, Ac-Powered Adjustable Hospital

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 44d17738-65f6-4124-8de1-4ea071cf709c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 22, 2016