AccessGUDID - DEVICE: Protekt Pilot (05060488571787)

GUDID

Device Identifier (DI) Information

Brand Name: Protekt Pilot
Version or Model: UPWLKALDLX19BL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UPWLKALDLX19BL
Company Name: PROACTIVE MEDICAL PRODUCTS, LLC

Primary DI Number: 05060488571787
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078582655 *Terms of Use

Device Description: Protekt Pilot Upright Walker Aluminum w/ Stand Assist Handles w/ 19" Seat w/ LED Light - Blue

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?
37953	Standing transfer platform, manual	A manually-operated device designed as a platform for use by healthcare professionals to assist in the physical moving (transfer) of a patient with a disability in an upright (standing) position over a short distance on a horizontal plane. Sometimes referred to as a rota stand it consists of a wheeled platform with a low centre of gravity and a surrounding framework, shinpad and/or handlebar; it may include body securing devices (e.g., belts, foot straps, knee pads) to hold the person being transferred in the standing position. It is neither intended to mechanically assist standing nor facilitate gait.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITJ	Walker, Mechanical

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: 30 Inch
Width: 19 Inch
Height: 71 Inch

Device Record Status

Public Device Record Key: d67e925d-b572-4c1e-9ac6-f09f8145d6bb
Public Version Date: August 05, 2022
Public Version Number: 2
DI Record Publish Date: April 12, 2021