FDA.reportPublic FDA data

Vicks

Primary DI
10328785001997
Brand
Vicks
Company
KAZ, INC.
Model
VDT972SP
Device description
TWO SECOND DIGITAL THERMOMETER W/ FEVER INSIGHT, FLEXIBLE TIP, F/C READINGS
Published
2018-11-30
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
K180131000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180131000Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company2018-08-14FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10328785001997PackageGS112In Commercial Distribution
00328785001990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1032878500199710328785001997
00328785001990003287850019903287850019900328785001990

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, battery-powered, electronic instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-477-0457consumerrelations@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
50328785524654VicksV966SP2025-05-05
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

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