AccessGUDID - DEVICE: Mobi-tools (08436035359592)

GUDID

Device Identifier (DI) Information

Brand Name: Mobi-tools
Version or Model: TMK6800
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDI CARE SYSTEM SLU

Primary DI Number: 08436035359592
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 511139446 *Terms of Use

Device Description: Kit containing 8 tools, 1 technical manual and 1 bag to keep everything inside, for patient transfer and mobilization

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?
40538	Manual patient lifting belt/harness	A device used to assist healthcare professionals or attending persons to physically move and lift a patient or a person with a disability (e.g., from the floor to a bed). The device is typically made strong textile materials (e.g., nylon or canvas) consisting of belts/harnesses. The device will typically require two persons to safely perform the lift. This is a reusable device.	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
No Device Sizes

Device Record Status

Public Device Record Key: 6bbb77fa-d798-4159-88cd-9f9239801753
Public Version Date: November 26, 2019
Public Version Number: 1
DI Record Publish Date: November 18, 2019