AccessGUDID - DEVICE: Parasol Wireless Patient Fall Prevention System (00854636006482)

GUDID

Device Identifier (DI) Information

Brand Name: Parasol Wireless Patient Fall Prevention System
Version or Model: WNCI-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Parasol Medical, LLC

Primary DI Number: 00854636006482
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079786058 *Terms of Use

Device Description: Wireless Nurse Call Interface

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?
62168	Nurse call system alarm	An electronic device intended to provide an audible sound and/or a visual display, typically coloured flashing lights or scrolling text, to notify a medical professional that (urgent) assistance is needed by a patient. It may be in the form of dome lights, basic visual display screens, and/or beeping devices which are triggered by manual or automatic alert activators (e.g., bedside push-button, ambulatory fall sensor, bed occupancy sensor) [not included]; it may function independently or as a component of a nurse call system via the healthcare facility hardwired or wireless network.	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
Device Size Text, specify: Mono Plug Diameter: 0.25 Inch

Device Record Status

Public Device Record Key: 072b24e3-68fe-4fa8-a08a-ec4f3d4b6949
Public Version Date: December 15, 2022
Public Version Number: 1
DI Record Publish Date: December 07, 2022