AccessGUDID - DEVICE: VELA Rumba (05714339123358)

GUDID

Device Identifier (DI) Information

Brand Name: VELA Rumba
Version or Model: 87215 Treatment chair
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Vermund Larsen A/S

Primary DI Number: 05714339123358
Issuing Agency: GS1
Commercial Distribution End Date: June 10, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 305793176 *Terms of Use

Device Description: Treatment chair for adult people

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?
47117	Haemodialysis chair, electric	A mains electricity (AC-powered) device designed to support the patient in a seated or reclined posture during haemodialysis procedures. It is usually made of easily washable materials, with appropriate arm, back, and footrests that can be adjusted by the patient using a powered mechanism. It provides interface with the dialysis system, facilitating the patient connection to the extracorporeal blood circuit.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INM	Chair, With Casters

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: 86ab7df4-68fc-4083-a34d-bd04c50a3e00
Public Version Date: June 18, 2025
Public Version Number: 1
DI Record Publish Date: June 10, 2025