AccessGUDID - DEVICE: Titan - Tollos (00817956026714)

GUDID

Device Identifier (DI) Information

Brand Name: Titan - Tollos
Version or Model: FPL1010X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 1073849 Ontario Limited

Primary DI Number: 00817956026714
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 049181763 *Terms of Use

Device Description: 1000 Lbs capacity Bariatric Medical Lift Hydraulic system Standard legs/casters Bariatric spreader bar Smart controls Internal battery

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?
12330	Mobile patient lifting system, electrically-powered	An electrically-powered, mobile assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort. Also known as a patient hoist, it typically consists of a support base on wheels with a motorized lifting mechanism, mast, boom/lifting arm(s), swivel bar, a patient holding device (e.g., a sling, holder or a frame). It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSA	Lift, Patient, Non-Ac-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
Weight: 490 Pound
Height: 72 Inch
Width: 42 Inch
Depth: 75 Inch

Device Record Status

Public Device Record Key: 2ceeebbd-fd2a-4eef-94d6-cea65625d7cb
Public Version Date: July 01, 2024
Public Version Number: 1
DI Record Publish Date: June 21, 2024