VivaGuard® HA-650 Non-Contact Infrared Forehead Thermometer - Accurate and Quick:(1) Advanced infrared - Able Diagnostics Inc

Duns Number:080952036

Device Description: Accurate and Quick:(1) Advanced infrared technology with a unique Chromed Arched Reflector 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.

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More Product Details

Catalog Number

HA-650

Brand Name

VivaGuard® HA-650 Non-Contact Infrared Forehead Thermometer

Version/Model Number

HA-650

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190984

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

dbbd7278-d27f-4aa7-a2fb-b2bb7b1f1a47

Public Version Date

December 16, 2020

Public Version Number

1

DI Record Publish Date

December 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABLE DIAGNOSTICS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 12