AccessGUDID - DEVICE: BioSerenity-Link (03615220003785)

GUDID

Device Identifier (DI) Information

Brand Name: BioSerenity-Link
Version or Model: 5100-00021-UN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BIOSERENITY MEDICAL DEVICES GROUP

Primary DI Number: 03615220003785
Issuing Agency: GS1
Commercial Distribution End Date: January 21, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 281224773 *Terms of Use

Device Description: BioSerenity-Link is a mobile application capable of sharing phone connectivity, recording video and uploading it to the BioSerenity Cloud

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?
38683	Camera application software	A data program designed for use in, or together with, a camera (e.g., a digital camera or video recorder) so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.	Active	false
32547	Medical networking interface unit	An electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.	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: 61f71c26-b43a-4121-bb65-1cb40140abc4
Public Version Date: January 23, 2025
Public Version Number: 4
DI Record Publish Date: January 12, 2023