Body Temperature Sensing Software FB611

GUDID 00810073612327

The Body Temperature Software (BTS) is a mobile medical application available to its intended users via their mobile device. The Body Temperature Software (BTS) collects and analyzes temperature data obtained via the infrared sensor built into the smartphone to approximate the user's rectal temperature which is then displayed on the application's user interface. The Body Temperature Software (BTS) is a pre-installed application on the Pixel 8 Pro with Android 14 operating system release or higher.

Fitbit LLC

Infrared patient thermometer, skin

• Primary Device ID: 00810073612327
• NIH Device Record Key: 98ec376c-b93a-4ec2-80df-69d86f2a7e65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Body Temperature Sensing Software
• Version Model Number: FB611
• Catalog Number: FB611
• Company DUNS: 829454672
• Company Name: Fitbit LLC
• 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: true

Customer Support Contacts

• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com
• Phone: +1(877) 623-4997
• Email: support@fitbit.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810073612327 [Primary]

FDA Product Code

• QZA: Body Temperature Sensing Software

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: 2025-09-24
• Device Publish Date: 2025-09-16

Devices Manufactured by Fitbit LLC

• 00810073612327 - Body Temperature Sensing Software: 2025-09-24The Body Temperature Software (BTS) is a mobile medical application available to its intended users via their mobile device. The Body Temperature Software (BTS) collects and analyzes temperature data obtained via the infrared sensor built into the smartphone to approximate the user's rectal temperature which is then displayed on the application's user interface. The Body Temperature Software (BTS) is a pre-installed application on the Pixel 8 Pro with Android 14 operating system release or higher.
• 00810073612327 - Body Temperature Sensing Software: 2025-09-24 The Body Temperature Software (BTS) is a mobile medical application available to its intended users via their mobile device. The
• 00810073612334 - Loss of Pulse Detection: 2025-09-24 The Loss of Pulse detection SaMD is intended to be used for the detection of loss of pulse using photoplethysmography (PPG) and
• 00898628002038 - Aria: 2025-09-12 The ARIA WiFi Smart Scale uses the Bioelectrical Impedance Analysis (BIA) technique to measure body fat composition by sending a
• 00898628002045 - Aria: 2025-09-12 The ARIA WiFi Smart Scale uses the Bioelectrical Impedance Analysis (BIA) technique to measure body fat composition by sending a