AccessGUDID - DEVICE: Medisoft (G407870A0)

GUDID

Device Identifier (DI) Information

Brand Name: Medisoft
Version or Model: 870 A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 870 A
Company Name: MEDISOFT RAM ITALIA SRL

Primary DI Number: G407870A0
Issuing Agency: HIBCC
Commercial Distribution End Date: December 05, 2033
Device Count: 1
Labeler D-U-N-S® Number*: 433868669 *Terms of Use

Device Description: Treadmill 870 A

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?
36679	Cardiopulmonary stress exercise treadmill	An electrically-powered device designed to be used as a component of a stress test system that permits the evaluation of a patient's physiologic response to physical stress (e.g., workload testing of the cardiac and/or pulmonary disorders/function). It is designed for walking, jogging, or running on a moving belt that facilitates physical exercise while the patient remains on the spot (i.e., treadmill). It consists of an endless, continuous track (e.g., a shock-absorbing rubber belt rotating on rollers) that rotates at varying speeds and elevation, electric motors, and controls. It will typically incorporate front and side-mounted rails to allow the user to steady themselves.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IOL	Treadmill, 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: 07c568ce-2136-490f-aaba-4951a83686a4
Public Version Date: December 13, 2023
Public Version Number: 1
DI Record Publish Date: December 05, 2023