AccessGUDID - DEVICE: Parasol Wireless Patient Fall Prevention System (00854636006475)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00854636006475
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079786058 *Terms of Use

Device Description: Wireless Seatbelt

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?
13356	Wheelchair/chair/stander occupant restraint/support	A rigid or non-rigid device, typically a strap, belt, bar, harness or vest designed to be attached to a wheelchair/chair/stander and/or its occupant to stabilize the occupant’s position for prevention of slips and/or falls from the appliance and/or to provide postural support. Some types may also be used to secure a wheelchair occupant in a wheelchair while travelling in a motor vehicle. This device may also include the extensions needed to attach this device and may be available in various sizes.	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
Length: 59 Inch

Device Record Status

Public Device Record Key: 9c03e0ee-e5b2-48f7-8d4c-62297571501d
Public Version Date: October 18, 2023
Public Version Number: 3
DI Record Publish Date: December 07, 2022