FDA.reportPublic FDA data

Good Sense

Primary DI
10846036006435
Brand
Good Sense
Company
GEISS, DESTIN & DUNN, INC
Model
69-352
Device description
60 Second Rigid Digital Thermometer
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K041516000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041516000DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9Vega Technologies, Inc.2004-09-08FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10846036006435PackageGS136In Commercial Distribution
30846036006439PackageGS16In Commercial Distribution
00846036006438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084603600643510846036006435
3084603600643930846036006439
00846036006438008460360064388460360064380846036006438

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
1-866-696-0957xx@xx.xx

Regulatory Flags#

DUNS number
076059836
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846036009453GOODSENSEG6009452025-01-16
00846036209457GOODSENSEG6009452025-01-16
00846036009446GOODSENSEG6009442022-05-03
00846036006438Good Sense69-3522016-09-23
00846036007671Good Sense69-3582016-09-23
00846036009774GOODSENSEG6009772025-01-16
00180410000880GoodSense1804100008802020-08-28
00180410000897GoodSense1804100008972020-08-28
00846036009606Good SenseKC009609MPSA1201GSGS2024-02-13
00846036006391Good Sense One Step Pregnancy TestFPPL2016-06-30
00846036009170Good SenseOne Step Pregnancy Test2020-09-21
00846036009187Good SenseOne Step Pregnancy Test2020-09-21
00846036006179Good Sense Early Result Pregnancy TestPLPL2016-06-30
00846036006186Good Sense Early Result Pregnancy TestPLPL2016-06-30
00846036006407Good Sense One Step Pregnancy TestFPPL2016-06-30
00846036002034Good SenseDS00203DS002032022-06-21
10846036002031Good SenseDS00203DS002032022-06-21
00846036000184Good Sense TamponsBGSAS202016-09-20
00846036000337Good Sense TamponsBGSAR082016-09-20
00846036003161Good Sense TamponsBGSGR202016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
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B3944670047010WVSM 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