VivaGuard® HA-650 Non-Contact Infrared Forehead Thermometer HA-650

GUDID 00853483008250

Accurate and Quick: (1) Advanced infrared technology with a unique Chromed Arched Reflector provides highly accurate and quick measurements in 1 second; (2) Features wide body temperature measuring range between 93.2°F – 109.4°F; (3) Offers reliable results in a wide environmental temperature range at 50.0°F – 104.0°F; No Touch and Safer Measurements: (1) Hold the Non-contact thermometer 0.4 – 2 inches away from the center of forehead to obtain measurement; (2) No measuring sensor cover is needed; (3) Minimizes the risk of spread of disease and cross-contamination; (4) Eliminates the need for cleaning between each person; Easy to Use: (1) Easy to read digital LCD display includes 3 backlight colors and features Red High Fever Alert above 101.3°F; (2) User-friendly design offers comfortable grip; (3) Storage for up to 50 measurement memories; (4) Switchable between °F/°C and beep/silent options; (5) 2 AAA batteries included.

Able Diagnostics Inc

Infrared patient thermometer, skin

• Primary Device ID: 00853483008250
• NIH Device Record Key: dbbd7278-d27f-4aa7-a2fb-b2bb7b1f1a47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VivaGuard® HA-650 Non-Contact Infrared Forehead Thermometer
• Version Model Number: HA-650
• Catalog Number: HA-650
• Company DUNS: 080952036
• Company Name: Able 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: 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853483008250 [Primary]

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: 2020-12-16
• Device Publish Date: 2020-12-08

Devices Manufactured by Able Diagnostics Inc

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• 00853483008038 - VivaGuard: 2021-02-17 VivaGuard Lancing Device
• 00853483008137 - VivaGuard: 2021-02-17 VivaGuard Safety Lancets (100s)
• 00853483008144 - VivaGuard: 2021-02-17 VivaGuard Lancets 100s (30G)
• 00853483008076 - VivaGuard Ino: 2021-02-11 VivaGuard Ino Control Solution (L, M, H, 1 bottle/each)
• 00853483008175 - VivaGuard Ino: 2021-02-11 VivaGuard Ino Control Solution 2 (1 bottle/kit)
• 00853483008182 - VivaGuard Ino: 2021-02-11 VivaGuard Ino Test strips 50s (50s/vial)
• 00853483008199 - VivaGuard Ino: 2021-02-11 VivaGuard Ino Control Solution (1 & 3)