FDA.reportPublic FDA data

Actherm

Primary DI
06972325560269
Brand
Actherm
Company
Dongguan Actherm Medical Corp.
Model
ACT8000-C
Published
2019-06-14
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090031000ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010Actherm, Inc.2009-04-16FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972325561242PackageGS110In Commercial Distribution
06972325560269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972325561242069723255612426972325561242
06972325560269069723255602696972325560269

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, earA hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544571542
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972325560177ForeHealthACT3020-XX2019-06-14
06972325560184ForeHealthACT3020 +-XX2019-06-14
06972325560191ForeHealthACT3020 Ex-XX2019-06-14
06972325560252ForeHealthACT3230 Basal2019-06-14
06972325561266ActhermProbe Cover2019-06-14
06972325560276ActhermACT8000-S2019-06-14
06972325560283ActhermACT8000-b2019-06-14
06972325560290ActhermACT8000-D2019-06-14
06972325560313ActhermProbe Cover2019-06-14
06972325560009Actherm2030+2019-06-14
06972325560016Actherm20302019-06-14
06972325560030Actherm2030 Ex2019-06-14
06972325560047Actherm2030+Ex2019-06-14
06972325560054Actherm20202019-06-14
06972325560061Actherm2020+2019-06-14
06972325560078Actherm2020 Ex2019-06-14
06972325560085Actherm2020+Ex2019-06-14
06972325560092Actherm21302019-06-14
06972325560108Actherm2130+2019-06-14
06972325560115Actherm2130 Ex2019-06-14

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Primary DI, Brand, Company table
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00198953009567Carescape ONEGE Healthcare Finland OyFLL2026-10-04
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00749756389204DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
06944413835153Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
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06931973457093CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
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06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28