FDA.reportPublic FDA data

Oral Temp Digital Thermometer

Primary DI
00891237001546
Brand
Oral Temp Digital Thermometer
Company
HOME AIDE DIAGNOSTICS, INC.
Model
MT4035
Catalog number
1546
Device description
Features:~ Flexible tip for convenient use~ Accurate to ±0.1 °C / ±0.2 °F~ Waterproof~ Large easy-to-read LCD~ Last memory recall~ Fever alarm~ Low battery indicator~ Automatic shut-off~ For oral, rectal, or axillary use
Published
2016-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
10891237001543PackageGS112In Commercial Distribution
30891237001547PackageGS18In Commercial Distribution
00891237001546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089123700154310891237001543
3089123700154730891237001547
00891237001546008912370015468912370015460891237001546

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature32 Degrees Celsius42.9 Degrees Celsius
Handling Environment Temperature90 Degrees Celsius109.9 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-915-0116info@homeaide.us

Regulatory Flags#

DUNS number
783518983
Device count
1
Lot or batch
true

Other Devices From This Company#

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00850027494975Easy Comfort Pro Insulin Syringes 31g 5/16” 1cc 40 count49752024-10-08
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00850027494999Easy Comfort Pro Insulin Syringes 30g 0.5in 1cc 40 count49992024-10-08
00891237001034Comfort Heal Heating PadJY610110342018-02-14
00850027494517Smart Neb Pediatric NebulizerSNebPN2023-11-03
00850632007225Easy NebMCN-S600MB72252018-01-26
00850632007553Pure Air Mini NebulizerMCN-S600A2020-03-24
00891237001607Easy Air Compressor NebulizerMCN-S600MC16072016-05-01
00850058864082Easy Comfort 3L Sharps Container {3.17 Quarts}SC3L2024-06-14
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