FDA.report

Vicks

Primary DI
20328785004674
Brand
Vicks
Company
KAZ USA, INC.
Model
V912BBUSV2
Device description
Vicks SpeedRead Pediatric Version
Published
2026-02-04
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
true

Related Records

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K043110000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20328785004674PackageGS124In Commercial Distribution
00328785004670PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
122612547
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

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