AccessGUDID - DEVICE: NA (10810030860096)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM131
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM131
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030860096
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: Replacement cover for corresponding size of patient transfer roller board. Over time, covers get worn and damaged. This cover slides over the rollers in place of the original cover and creates a "like new" board again. Guaranteed to fit Mid Central Medical roller boards, may or may not work with other manufacturers roller boards.

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?
37164	Patient position turntable	A non-powered, manual device typically in the form of a rotating flat plate/disk intended to be positioned under a patient's buttocks or feet (when standing) to allow healthcare provider to pivot the patient for a change in position or direction, typically to facilitate proximal patient transfer (e.g., from bed to toilet); it has no lifting capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMR	Device, Transfer, Patient, Manual

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
Length: 67 Inch
Width: 15 Inch

Device Record Status

Public Device Record Key: 4c88bbf5-9675-4e86-9776-9dde04384cb3
Public Version Date: August 05, 2022
Public Version Number: 2
DI Record Publish Date: September 01, 2020