FDA.reportPublic FDA data

ForeHealth

Primary DI
06972325560252
Brand
ForeHealth
Company
Dongguan Actherm Medical Corp.
Model
ACT3230 Basal
Device description
Thermometer ACT3230 Basal for cycle control This clinical digital thermometer is suitable for determining the basal temperature for natural family planning in the private sector. It measures the smallest changes in the temperature profile of the female cycle to determine the best days of conception. The Thermometer is also suitable for measuring body temperature.
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
K070028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070028000CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETERActherm, Inc.2007-02-08FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972325560528PackageGS112In Commercial Distribution
06972325560733PackageGS1324In Commercial Distribution
06972325560986PackageGS1100In Commercial Distribution
06972325561235PackageGS1600In Commercial Distribution
06972325560252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972325560528069723255605286972325560528
06972325560733069723255607336972325560733
06972325560986069723255609866972325560986
06972325561235069723255612356972325561235
06972325560252069723255602526972325560252

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.

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
06972325561266ActhermProbe Cover2019-06-14
06972325560269ActhermACT8000-C2019-06-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22