FDA.reportPublic FDA data

LinkTemp

Primary DI
00851028001391
Brand
LinkTemp
Company
LINKS MEDICAL PRODUCTS INC
Model
LMP001
Catalog number
LMP001
Device description
Non-Contact Infrared Thermometer
Published
2016-10-24
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130231000NON-CONTACT INFRARED THERMOMETERJinxinbao Electronic Co.,Ltd2013-10-15FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851028001391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851028001391008510280013918510280013910851028001391

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
Special Storage Condition, Specify00Fragile; Keep dry
Storage Environment Atmospheric Pressure5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-753-0001scampbell@linksmed.com

Regulatory Flags#

DUNS number
839081445
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851028001100LMP Manuka FillWC07WC072024-01-12
00851028001162LMP Manuka IGWC20WC202024-01-12
00851028001353LMP Manuka IG MaxWC25WC252024-01-12
00851028001377LMP Manuka IG Max RopeWC37WC372024-01-12
00851028001407LMP Manuka Foam AirWC70WC702024-01-12
00851028001094LMP Manuka FillWC05WC052024-01-12
10851028001107LMP Manuka FillWC07WC072024-01-12
10851028001169LMP Manuka IGWC20WC202024-01-12
10851028001350LMP Manuka IG MaxWC25WC252024-01-12
10851028001374LMP Manuka IG Max RopeWC37WC372024-01-12
10851028001404LMP Manuka Foam AirWC70WC702024-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120095900809SteadyTempSteadySense GmbHFLL2026-10-21
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00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyFLL2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyFLL2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyFLL2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyFLL2026-10-04
00749756389181DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
00749756389204DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
06944413835153Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
00885403523437HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
00885403523451HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
00885403523475HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
06970289030859foreverlittleHetaida Technology Co., LtdFLL2026-07-28
06953825911638ZKZOShenzhen Urion Technology Co., LtdFLL2026-07-23
B353UB25511UbiqVue MultiparameterLifesignals, Inc.FLL2026-07-20
06972040114334N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040114341N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040115522N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06931973457093CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06931973457109CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758502641CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758508865CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.FLL2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.FLL2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29