FDA.reportPublic FDA data

KenTemp

Primary DI
00810003751850
Brand
KenTemp
Company
KENTRON HEALTHCARE, INC.
Model
DT-3334
Catalog number
DT3334
Device description
Digital Thermometer
Published
2021-04-29
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
K163603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163603000Digital ThermometerGuangzhou Jinxinbao Electronic Co., Ltd.2017-06-06FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810003751850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810003751850008100037518508100037518500810003751850

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

Contacts#

Phone, Email table
PhoneEmail
615-384-0573kentron@kentronmedical.com

Regulatory Flags#

DUNS number
618825723
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810003750495KENTRON7499252026-06-01
00810003750501KENTRON7499302026-06-01
00810003750518KENTRON7499352026-06-01
00810003750525KENTRON7499402026-06-01
00810003750532KENTRON7499452026-06-01
00810003750549KENTRON7499502026-06-01
00810003750556KENTRON7499552026-06-01
00810003750563KENTRON7499602026-06-01
00810003750570KENTRON7499652026-06-01
00810003750587KENTRON7499702026-06-01
00810003750594KENTRON7499752026-06-01
00810003750600KENTRON7499802026-06-01
00810003750617KENTRON7499852026-06-01
00810003750624KENTRON7499902026-06-01
00810003750631KENTRON7499952026-06-01
00810003750648KENTRON7491002026-06-01
00810003750655KENTRON7699252026-06-01
00810003750662KENTRON7699302026-06-01
00810003750679KENTRON7699352026-06-01
00810003750686KENTRON7699402026-06-01

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