AccessGUDID - DEVICE: DRIVEMEDICAL (00822383934198)

GUDID

Device Identifier (DI) Information

Brand Name: DRIVEMEDICAL
Version or Model: 13031SV-KD
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822383934198
Issuing Agency: GS1
Commercial Distribution End Date: June 22, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: Patient RoomStools (physicians) Product Description: FootStool,DLX wHNDL,Silvervein,KD1EA/4CV

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?
11772	Footstool	A platform, with or without legs, designed for a person to stand upon to compensate for differences in height or to place the feet/legs upon for rest/support when seated. It may be conductive to reduce the risk of static electricity when used in areas such as examination rooms or operating theatres, or non-conductive.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILS	ADAPTOR, HYGIENE

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: 24a4e3ad-fe96-4e25-954c-73bd3d115eec
Public Version Date: October 07, 2024
Public Version Number: 2
DI Record Publish Date: June 21, 2019