AccessGUDID - DEVICE: MedSurg Manual Bed (00670482000029)

GUDID

Device Identifier (DI) Information

Brand Name: MedSurg Manual Bed
Version or Model: FL23P
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FL23P
Company Name: Umano Medical Inc

Primary DI Number: 00670482000029
Issuing Agency: GS1
Commercial Distribution End Date: November 08, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 249675476 *Terms of Use

Device Description: MedSurg Manual Bed

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
34873	Manual hospital bed	A mechanical bed designed to be used as a patient bed for rest/sleep in a hospital ward/room with manual mechanisms to adjust the height and surface contour of the bed. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and mechanical manually-operated controls to operate the bed.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNJ	Bed, Manual

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: f66d3085-0bf8-4240-ac46-b0a9e499c6e6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016