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VivaGuard® HA-650 Non-Contact Infrared Forehead Thermometer

FDA UDI

Class II (US FDA UDI)

by Able Diagnostics Inc

Identity

Trade Name
VivaGuard® HA-650 Non-Contact Infrared Forehead Thermometer FDA UDI
Generic Name
Infrared patient thermometer, skin FDA UDI
Device Name
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. FDA UDI
Model / Reference
HA-650 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
HA-650 FDA UDI
Primary DI / UDI-DI
00853483008250 FDA UDI
510(k) Number
K190984 FDA UDI
FDA Product Code
FLL FDA UDI
GMDN Term
Infrared patient thermometer, skin FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2910 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Infrared patient thermometer, skin

VivaGuard® HA-650 Non-Contact Infrared Forehead Thermometer by Able Diagnostics Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infrared patient thermometer, skin.

Cleared under the same submission

K190984 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Able Diagnostics Inc

Sources (1)

  • FDA UDI dbbd7278-d27f-4aa7-a2fb-b2bb7b1f1a47 35 fields · synced May 30, 2026