AccessGUDID - DEVICE: DRIVE (00822383000855)

GUDID

Device Identifier (DI) Information

Brand Name: DRIVE
Version or Model: 795RG
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822383000855
Issuing Agency: GS1
Commercial Distribution End Date: April 24, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use
Previous DI: 00822384002186

Device Description: Rollators 4-Wheel Alum. Product Description Duet Rollator/TransportChair,Rose, 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?
17105	Walking aid handgrip	A device designed to help a person using a walking aid to grasp the walking aid (e.g., a walking stick, cane, crutch, walking frame or rollator) securely. Included are adjustable grips, grips with antislip material and grips of special material such as foam. This is a reusable device.	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
No Device Sizes

Device Record Status

Public Device Record Key: 47a677d1-42d3-47d5-8202-0bb46688e838
Public Version Date: April 24, 2020
Public Version Number: 2
DI Record Publish Date: February 08, 2020