AccessGUDID - DEVICE: Universal Mattress Cover with Defined Perimeter (00616784048512)

GUDID

Device Identifier (DI) Information

Brand Name: Universal Mattress Cover with Defined Perimeter
Version or Model: 10485
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00616784048512
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: 80" x 36" x 6"

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?
62365	Bed mattress/cover set	A collection of devices designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep, and which may help to promote therapeutic postures. It typically consists of a bed mattress, mattress overlay/cover and wedge-shaped cushion which are typically made of knitted polyester, polyurethane foam, buckwheat husk or combinations of materials. This is a reusable device after appropriate cleaning.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMW	Cover, Mattress (Medical Purposes)

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: ac6e0016-88b9-41ed-aebd-826ab9ca8186
Public Version Date: October 09, 2024
Public Version Number: 3
DI Record Publish Date: April 21, 2022