AccessGUDID - DEVICE: Drive (00822384002063)

GUDID

Device Identifier (DI) Information

Brand Name: Drive
Version or Model: CX418DDA-ELR
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822384002063
Issuing Agency: GS1
Commercial Distribution End Date: June 21, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: Transport chairs/Wheelchairs Wheelchairs K4 Product Description CruiserX4, 18" DetDsk Arm, ElvLg, 1/ea

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":	Yes
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?
30040	Portable ramp	A portable sloping surface designed to bridge a limited gap between two levels. It is used to move objects or persons from one level to another level. The device would typically be used by a person with a disability in a wheelchair needing to move from one level to another in order to enter or exit a vehicle, e.g., an adapted van or a bus.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IOR	Wheelchair, mechanical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082784	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 78ea3caf-c68e-4a8a-be48-c3c7d5dd5ca6
Public Version Date: June 02, 2020
Public Version Number: 5
DI Record Publish Date: June 21, 2019