Cell Therapy 360 Wearable Tech V1

GUDID 00851203006234

BLUE SPARK TECHNOLOGIES, INC.

Wireless patient monitor/sensor reporting software

• Primary Device ID: 00851203006234
• NIH Device Record Key: dc689856-b354-4b31-b522-f1bea64a3083
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cell Therapy 360 Wearable Tech V1
• Version Model Number: 2.6.0.10813 CV
• Company DUNS: 603031365
• Company Name: BLUE SPARK TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851203006234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143267

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-29
• Device Publish Date: 2020-10-21

On-Brand Devices [Cell Therapy 360 Wearable Tech V1]

• 00851203006272: 2.3.0.10160 CV
• 00851203006265: 2.6.0.10768 PC
• 00851203006258: 2.6.0 (1099) R
• 00851203006241: 2.6.1 (1106) CV
• 00851203006234: 2.6.0.10813 CV
• 00851203006104: TT-300