TrackAid

GUDID 00864984000407

Dual Mode Digital Infrared Thermometer

TRIWALKER SERVICES LLC

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