TempTrend II

GUDID M74411001

BIOSYNERGY, INC.

Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use

• Primary Device ID: M74411001
• NIH Device Record Key: b1629f92-09fd-4446-ab39-833b730207df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TempTrend II
• Version Model Number: 1100
• Company DUNS: 070698154
• Company Name: BIOSYNERGY, INC.
• Device Count: 50
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com
• Phone: 800-255-5274
• Email: jaddis@biosynergyinc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M74411000 [Unit of Use]
HIBCC	M74411001 [Primary]
HIBCC	M74411002 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K833904

FDA Product Code

• KPD: Strip, Temperature, Forehead, Liquid Crystal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-01

Devices Manufactured by BIOSYNERGY, INC.

• M74420002 - HemoTemp: 2022-05-12
• M74450002 - StaFreez: 2022-05-12
• M74481001 - HemoCool Gel-Pak: 2022-05-12
• M74490001 - HemoTemp II Activator: 2022-05-12
• M74430001 - HemoTemp II: 2021-03-01
• M74460002 - LabTemp 20: 2021-03-01
• M74461001 - LabTemp 40: 2021-03-01
• M74410002 - TempTrend: 2020-02-24