AccessGUDID - DEVICE: Genesis Touch Tab A 8.4

GUDID

Device Identifier (DI) Information

Brand Name: Genesis Touch Tab A 8.4 - RCT
Version or Model: 6055526B1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mobilehelp, LLC

Primary DI Number: 00817644020161
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 023260604 *Terms of Use

Device Description: No description.

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):	Yes
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?
18118	Home healthcare information system	A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of home healthcare services and facilities. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical Device Data System

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: b099ce2c-833b-45c2-bdb9-a250cd9dac98
Public Version Date: October 26, 2022
Public Version Number: 2
DI Record Publish Date: March 31, 2021