AccessGUDID - DEVICE: Drive (00822383227320)

GUDID

Device Identifier (DI) Information

Brand Name: Drive
Version or Model: STD28ECDDA-ELR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822383227320
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: Transport/WheelchairWheelchairs K6 Product Description: SentraEC,28"HD.DetDskArm,ElvLg 1/cs

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):	Yes
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?
41630	Attendant-only-propelled wheelchair, non-bariatric	A non-powered wheeled mobility device with a seat designed to enable a healthcare provider/carer to transport a non-bariatric person without the full capacity to walk, typically over short distances and over smooth ground. Often referred to as a transport wheelchair, it is typically designed with four small wheels and includes rear-fitted handles for attendant control of the chair; it does not provide the occupant a mechanism for self-propulsion (it is not a push-rim wheelchair). It provides no function outside of wheeled mobilization.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IOR	Wheelchair, mechanical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cb1e4f83-2608-439b-8363-1219c9ee7b9d
Public Version Date: September 24, 2024
Public Version Number: 2
DI Record Publish Date: June 21, 2019