AccessGUDID - DEVICE: REMOVABLE PATIENT CONTROL

GUDID

Device Identifier (DI) Information

Brand Name: REMOVABLE PATIENT CONTROL – 5 FUNCTIONS
Version or Model: 299-0152-TRI
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 299-0152-TRI
Company Name: Umano Medical Inc

Primary DI Number: 00670482000869
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 249675476 *Terms of Use

Device Description: A hand-operated electronic device that has a functional connection to an electrically powered medical bed to control its operation.

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?
37991	Bed remote control	A hand-operated electronic device that has a functional connection to an electrically-powered medical bed to control its functions, typically the articulations and/or the raising/lowering of the bed. It may be connected to the bed via an electrical cable or operate cordless (wireless). It is typically operated by the occupant but may be utilized by the nursing/attending staff. Some types may integrate other functions for patient use (e.g., communication with the staff, radio/television operation).	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6adbb7fe-ee19-4aea-b431-6309390d12d6
Public Version Date: September 25, 2024
Public Version Number: 1
DI Record Publish Date: September 17, 2024