FDA.reportPublic FDA data

ArroTemp Infrared Thermometer

Primary DI
00869937000039
Brand
ArroTemp Infrared Thermometer
Company
ARROWHEAD HEALTHCARE SUPPLY, LLC
Model
P-108425
Device description
ArroTemp Infrared non-contact Thermometer
Published
2016-09-22
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
10869937000036PackageGS19In Commercial Distribution
20869937000033PackageGS116In Commercial Distribution
00869937000039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086993700003610869937000036
2086993700003320869937000033
00869937000039008699370000398699370000390869937000039

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.

Regulatory Flags#

DUNS number
078585060
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852685007009ArroAir DigiMax 8 LPM pumpP-1080732016-09-23
00852685007023ArroAir Max Pump OnlyP-1080572016-09-23
00869937000091ArroAir Pro Bariatric 14LPM PumpP-1080692016-09-22
00869937000022ArroAir EliteP-1080502016-09-22
00852685007016ArroAir Deluxe LAL/AP Mattress w/ DigiMax PumpP-1086772016-09-23
00852685007030ArroAir Premier LAL/AP Mattress w/ DigiMax PumpP-1086782016-09-23
10869937000029ArroAir EliteP-1080502016-09-22
10869937000036ArroTemp Infrared ThermometerP-1084252016-09-22
00869937000046ArroAir Max & EssentialP-1080542016-09-16
00869937000053ArroAir Max & DeluxeP-1080602016-09-22
00869937000060ArroAir Max & PremierP-1080702016-09-22
00869937000077"ArroAir 42"" Bariatric AP Mattress System"P-108068-422016-09-22
00869937000084"ArroAir 48"" Bariatric AP Mattress System"P-108068-482016-09-22

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