AccessGUDID - DEVICE: Drive (00779709060447)

GUDID

Device Identifier (DI) Information

Brand Name: Drive
Version or Model: RTL6044
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00779709060447
Issuing Agency: GS1
Commercial Distribution End Date: June 26, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: Personal CareAids to Daily Living Product Description: 24" Transfer Board w/Handles,1EA,2/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):	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?
37162	Patient transfer sliding board	A manual device used by healthcare professionals to assist in the physical movement and transfer of a person/patient (e.g., a hospitalized, a person with a disability, or a geriatric) from one position to another. The device typically has no lifting capabilities and utilizes sliding techniques to move the person. It is typically designed to transfer a person sideways from, e.g., a bed to a chair, or a bed to an operating table, or an operating table to a bed. It may be constructed as a solid sliding board with a low-friction surface, or a roller board (roller system in a framework).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKX	AID, TRANSFER

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: 781e2869-0dbd-46b0-a4e2-36e6715d8ba3
Public Version Date: July 03, 2019
Public Version Number: 1
DI Record Publish Date: June 25, 2019