AccessGUDID - DEVICE: TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx (00841447100966)

GUDID

Device Identifier (DI) Information

Brand Name: TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx
Version or Model: TDXSP2-MCG
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INVACARE CORPORATION

Primary DI Number: 00841447100966
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076916246 *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):	Yes
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?
41875	Electric-motor-driven wheelchair, occupant-controlled	An electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITI	Wheelchair, powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170507	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between -40 and 65 Degrees Celsius
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -25 and 50 Degrees Celsius
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f1275bbc-21a2-4572-8c44-81ef90ff4f51
Public Version Date: April 22, 2024
Public Version Number: 4
DI Record Publish Date: August 14, 2017