FDA.reportPublic FDA data

Accuflex5 VU Thermometer, from Physio Logic

Primary DI
00057565166511
Brand
Accuflex5 VU Thermometer, from Physio Logic
Company
A.M.G. Médicale Inc
Model
016-651
Catalog number
016-651
Device description
Accurate readings in as little as 5 seconds. •Color feverline alert indicates if the reading is normal or if it represents a mild or high fever.•Large, backlit screen displays temperature in °C or °F.•Beeps when reading is complete.•Professional accuracy within 0.1°C (0.2°F).•Waterproof gentle–flex tip for added comfort & safety.•Recalls last reading.•Can be used orally, rectally, under the arm or to take bath water temperature.•Auto shut-off for extended battery life
Published
2018-05-16
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05756599922548PackageGS16In Commercial Distribution
05756599923224PackageGS112In Commercial Distribution
10057565166518PackageGS16In Commercial Distribution
20057565166515PackageGS112In Commercial Distribution
05756516651186PreviousGS10
00057565166511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
05756599922548057565999225485756599922548
05756599923224057565999232245756599923224
1005756516651810057565166518
2005756516651520057565166515
05756516651186057565166511865756516651186
00057565166511000575651665110575651665110057565166511

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent electronic patient thermometerA hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.

Regulatory Flags#

DUNS number
207372814
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00057565166184PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, Oral (Blue)016-618016-6182023-06-09
00057565166191PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, RECTAL (Red)016-619016-6192023-06-09
00057565166283Physio Logic Accuflex Digital Thermometer016-628016-6282023-06-09
00057565166290Physio Logic Accuflex Digital Thermometer - Red016-629016-6292023-06-09
00057565166481ACCUFLEXPRO+ ORAL THERMOMETER (BLUE)016-648016-6482023-06-09
00057565166498ACCUFLEXPRO+ RECTAL THERMOMETER (RED)016-649016-6492023-06-09
00057565964568PhysioLogic DigiPro+ 30 second Digital Oral Thermometer016-625016-6252023-06-09
00775757713175Avantia Ultra-Comfort Commode771-3172020-04-20
00775757713151Avantia Portable Steel Commode771-3152020-04-16
00057565168102FeverScan Fever Indicators by Physio Logic016-800016-8002023-06-13
00057565976042FeverScan Fever Indicators by Physio Logic016-800016-8002023-06-13
00775757154251ProActive Alevia 2 in 1 TENS715-425715-4252023-06-12
00775757079301Avantia BPM-70 Automatic Blood Pressure Monitor107-930107-9302023-06-09
00057565975106PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, Oral (Blue)016-618016-6182023-06-09
00057565975120PHYSIO LOGIC DIGIPRO+ DIGITAL THERMOMETER, RECTAL (Red)016-619016-6192023-06-09
00057565972846Physio Logic Accuflex Digital Thermometer016-628016-6282023-06-09
00057565972853Physio Logic Accuflex Digital Thermometer - Red016-629016-6292023-06-09
00057565973447ACCUFLEXPRO+ ORAL THERMOMETER (BLUE)016-648016-6482023-06-09
00057565973461ACCUFLEXPRO+ RECTAL THERMOMETER (RED)016-649016-6492023-06-09
00057565166252PhysioLogic DigiPro+ 30 second Digital Oral Thermometer016-625016-6252023-06-09

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