VivaGuard® HA-650 Non-Contact Infrared Forehead Thermometer

Primary DI
00853483008250
Brand
VivaGuard® HA-650 Non-Contact Infrared Forehead Thermometer
Company
Able Diagnostics Inc
Model
HA-650
Catalog number
HA-650
Device 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.
Published
2020-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190984000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190984000Infrared Forehead ThermometerXiamen Ants Bro Technology Co., Ltd.2020-04-22FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853483008250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853483008250008534830082508534830082500853483008250

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080952036
Device count
1
Lot or batch
true
No natural rubber latex
true

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Primary DI, Brand, Model table
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00853483008199VivaGuard InoVGC01VGC01-3722021-02-03
00853483008236VivaGuard Ino SmartVGM04VGM04-6652021-02-03
00853483008243VivaGuard Ino SmartVGM042021-02-03
00853483008007VivaGuard InoVGM01VGM01-3712021-02-02
00853483008014VivaGuard InoVGS01VGS01-3712021-02-02
00853483008052VivaGuard InoVGM01VGM01-3732021-02-02
00853483008151VivaGuard Ino VGM012021-02-02
00853483008021VivaGuardVGL01VGL01-3822021-02-09
00853483008038VivaGuardVGD01VGD01-3812021-02-09
00853483008137VivaGuardVGL02VGL02-3822021-02-09
00853483008144VivaGuardVGL01VGL01-3832021-02-09

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