FDA.reportPublic FDA data

Physiologic Insta-Therm Quick-Scan Thermometer

Primary DI
05756598834224
Brand
Physiologic Insta-Therm Quick-Scan Thermometer
Company
A.M.G. Médicale Inc
Model
016-670
Device description
This thermometer's innovative design offers 2 convenient and accurate ways to measure body temperature instantly.The Insta-Therm Quick-Scan’s innovati
Published
2017-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
05756598833548PackageGS16In Commercial Distribution
05756598834224PackageGS110In Commercial Distribution
10057565166709PackageGS16In Commercial Distribution
20057565166706PackageGS110In Commercial Distribution
00057565166702PrimaryGS10
05756516670200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
05756598833548057565988335485756598833548
05756598834224057565988342245756598834224
1005756516670910057565166709
2005756516670620057565166706
00057565166702000575651667020575651667020057565166702
05756516670200057565166702005756516670200

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, battery-powered, electronic 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
207372814
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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