AccessGUDID - DEVICE: oneNEST M Control unit (00670482000807)

GUDID

Device Identifier (DI) Information

Brand Name: oneNEST M Control unit
Version or Model: 303-MCU15NA115-BIL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 303-MCU15NA115-BIL
Company Name: Umano Medical Inc

Primary DI Number: 00670482000807
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 249675476 *Terms of Use

Device Description: The oneNEST M control unit (power cord 15 ft) is intended to be used with mattress oneNEST M. When connected to the mattress, it offers microclimate management with airflow

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?
36688	Alternating-pressure inflator	An electrically-powered device that forces ambient air into the parallel chambers of an alternating-pressure bed mattress overlay or an alternating-pressure chair cushion, for the timed alternation of chamber inflation and thereby exchange of patient contact points. The inflator, which may be referred to as a pump and may be programmable, ensures a regular exchange of the overlay/cushion pressure points for the patient.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IOQ	Bed, Flotation Therapy, Powered

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: 58a75ad2-b6ca-47ea-b4c7-8fc29fca6c89
Public Version Date: September 19, 2024
Public Version Number: 2
DI Record Publish Date: June 07, 2024