TrackAid

GUDID 00864984000407

Dual Mode Digital Infrared Thermometer

TRIWALKER SERVICES LLC

Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin

• Primary Device ID: 00864984000407
• NIH Device Record Key: dafa487a-3060-4020-9c0e-cebd999f145b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrackAid
• Version Model Number: TA-FR401
• Company DUNS: 080762333
• Company Name: TRIWALKER SERVICES 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: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864984000407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131243

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-01

On-Brand Devices [TrackAid]

• 00864984000490: TrackAid Fingertip Pulse Oximeter TA-500G White
• 00864984000452: TrackAid Fingertip Pulse Oximeter TA-50DL BLUE
• 00864984000445: Fingertip Pulse Oximeter
• 00864984000407: Dual Mode Digital Infrared Thermometer
• 00864984000476: TrackAid Finger Pulse Oximeter TA-50DL
• 00864984000438: TrackAid Finger Pulse Oximeter TA-60D Dark
• 00864984000469: TrackAid Finger Pulse Oximeter TA-50DL Pink