AccessGUDID - DEVICE: DRIVEMEDICAL (00822383513249)

GUDID

Device Identifier (DI) Information

Brand Name: DRIVEMEDICAL
Version or Model: M8064
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822383513249
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: Pressure PreventionSeat and Back Cushions Product Description: Premier One Foam Cushion18x16x3 1ea,4/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?
44361	Foam-filled chair cushion	A foam-filled pad designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair and may contain weight-distribution air cells. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KIC	CUSHION, FLOTATION
IMP	CUSHION, WHEELCHAIR

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: 956f3347-4c84-4d4d-b74d-37a107060813
Public Version Date: July 17, 2019
Public Version Number: 5
DI Record Publish Date: May 19, 2017