AccessGUDID - DEVICE: Rego Safe Mobility App (00840828192095)

GUDID

Device Identifier (DI) Information

Brand Name: Rego Safe Mobility App
Version or Model: Rego Safe Mobility App
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CURBELL MEDICAL PRODUCTS, INC.

Primary DI Number: 00840828192095
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796452311 *Terms of Use

Device Description: No description.

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?
63286	Inpatient motion surveillance software	A software program designed to be used in a healthcare setting to track the movements of an inpatient, typically a patient in a hospital side/isolation room or nursing home, to detect high-risk behaviour (e.g., bedridden patient bed vacation attempt, fall risk) and automatically send alert notifications to healthcare staff via a central monitoring station or nurse call system in response. It is used in conjunction with video surveillance motion sensors/cameras and is intended to analyse patient motion with respect to predetermined motion threshold references.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMI	Monitor, Bed Patient

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: 1df284b9-d3e2-4238-942e-4fe9deb7662e
Public Version Date: May 31, 2024
Public Version Number: 1
DI Record Publish Date: May 23, 2024