CHOSEN Infrared Forehead Thermometer FTH800

GUDID 00840423500523

CHOSEN Infrared Forehead Thermometer

ABOUND Diagnostics, Inc.

Infrared patient thermometer, ear/skin

• Primary Device ID: 00840423500523
• NIH Device Record Key: 620428cb-5612-41ed-ba84-eb9faa2f0167
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHOSEN Infrared Forehead Thermometer
• Version Model Number: FTH800
• Catalog Number: FTH800
• Company DUNS: 119217208
• Company Name: ABOUND Diagnostics, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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: 8889696928
• Email: lmariano@abounddiagnostics.com
• Phone: 8889696928
• Email: lmariano@abounddiagnostics.com
• Phone: 8889696928
• Email: lmariano@abounddiagnostics.com
• Phone: 8889696928
• Email: lmariano@abounddiagnostics.com
• Phone: 8889696928
• Email: lmariano@abounddiagnostics.com
• Phone: 8889696928
• Email: lmariano@abounddiagnostics.com
• Phone: 8889696928
• Email: lmariano@abounddiagnostics.com
• Phone: 8889696928
• Email: lmariano@abounddiagnostics.com
• Phone: 8889696928
• Email: lmariano@abounddiagnostics.com
• Phone: 8889696928
• Email: lmariano@abounddiagnostics.com
• Phone: 8889696928
• Email: lmariano@abounddiagnostics.com
• Phone: 8889696928
• Email: lmariano@abounddiagnostics.com
• Phone: 8889696928
• Email: lmariano@abounddiagnostics.com
• Phone: 8889696928
• Email: lmariano@abounddiagnostics.com
• Phone: 8889696928
• Email: lmariano@abounddiagnostics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840423500202 [Primary]
GS1	00840423500523 [Package]; Contains: 00840423500202; Package: carton [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190984

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: 2025-04-21
• Device Publish Date: 2025-04-11

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• 00840423500103 - VivaGuard Lancets (28G): 2025-04-21 VivaGuard Lancets (28G)
• 00840423500110 - VivaGuard Lancets (30G): 2025-04-21 VivaGuard Lancets (30G)
• 00840423500424 - VivaGuard Lancing Device: 2025-04-21 VivaGuard Lancing Device
• 00840423500486 - VivaGuard Safety Lancets (18G): 2025-04-21 VivaGuard Safety Lancets (18G)
• 00840423500158 - VivaGuard Safety Lancets (21G): 2025-04-21 VivaGuard Safety Lancets (21G)