FDA.reportPublic FDA data

Vicks

Primary DI
50328785524654
Brand
Vicks
Company
KAZ, INC.
Model
V966SP
Device description
VICKS DIGITAL THERMOMETER FOR SECONDARY PLACEMENT
Published
2025-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
K043110000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043110000MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1Microlife Intellectual Property GmbH2004-12-09FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50328785524654PackageGS112In Commercial Distribution
00328785524659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5032878552465450328785524654
00328785524659003287855246593287855246590328785524659

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
800-477-0457consumerrelations@kaz.com

Regulatory Flags#

DUNS number
001483890
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00328785524659VicksV966SP2025-05-05
00328785012132BraunIRT3575US2025-06-19
00328785002454VicksVEV7102025-05-05
00328785002478VicksVWC775V22025-05-05
10328785002451VicksVEV7102025-05-05
10328785002475VicksVWC775V22025-05-05
00328785002355HONEYWELLHUL900B2021-09-30
00328785002461Vicks VUL9002021-09-30
10328785002352HONEYWELLHUL900B2021-09-30
10328785002468Vicks VUL9002021-09-30
00328785002034VicksVNT200US2020-09-29
20328785002038VicksVNT200US2020-09-29
10328785004820VicksV4600V22020-04-03
10328785004837HoneywellHUL535WV22020-04-03
10328785004844HoneywellHUL535BV22020-04-03
10328785004875HoneywellHUL520LV32020-04-03
10328785004882HoneywellHUL520RV32020-04-03
10328785004868HoneywellHUL520BV32020-01-28
10328785003212VicksVUL6002019-12-30
10328785002406Braun BNA100US2019-11-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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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