AccessGUDID - DEVICE: Cell Therapy 360 Wearable Tech V1 (00851203006241)

GUDID

Device Identifier (DI) Information

Brand Name: Cell Therapy 360 Wearable Tech V1
Version or Model: BMS CT360 iOS Patient App
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BLUE SPARK TECHNOLOGIES, INC.

Primary DI Number: 00851203006241
Issuing Agency: GS1
Commercial Distribution End Date: February 25, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 603031365 *Terms of Use

Device Description: BMS CT360 iOS Patient App

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?
62169	Wireless patient monitor/sensor reporting software, layperson-use	A software program intended to be used by a layperson at home to receive data from a noninvasive, patient-worn, wireless monitor/sensor to display, record, and assist in analysis and healthcare provider reporting of the collected clinical data, typically for continuous monitoring and optional communication with a clinician. It may enable configuration of alert notifications and is typically installed on an off-the-shelf, portable, computerized device (e.g., smartphone, tablet); it is not dedicated to bedside monitoring.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: ff5e96bd-0aa7-428f-b9c9-2df6ac1a2b4a
Public Version Date: February 26, 2025
Public Version Number: 6
DI Record Publish Date: October 21, 2020