Vicks

GUDID 00328785000061

Thermometer, ComfortFlex, 8sec digital, w/Fever Insight

KAZ, INC.

Intermittent electronic patient thermometer

• Primary Device ID: 00328785000061
• NIH Device Record Key: f54f97bc-870e-469b-944a-bbd1d7044783
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vicks
• Version Model Number: V966USV1
• Company DUNS: 001483890
• Company Name: KAZ, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-477-0457
• Email: consumerrelations@kaz.com
• Phone: 1-800-477-0457
• Email: consumerrelations@kaz.com
• Phone: 1-800-477-0457
• Email: consumerrelations@kaz.com
• Phone: 1-800-477-0457
• Email: consumerrelations@kaz.com
• Phone: 1-800-477-0457
• Email: consumerrelations@kaz.com
• Phone: 1-800-477-0457
• Email: consumerrelations@kaz.com
• Phone: 1-800-477-0457
• Email: consumerrelations@kaz.com
• Phone: 1-800-477-0457
• Email: consumerrelations@kaz.com
• Phone: 1-800-477-0457
• Email: consumerrelations@kaz.com
• Phone: 1-800-477-0457
• Email: consumerrelations@kaz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00328785000061 [Primary]
GS1	10328785000068 [Package]; Package: Case [12 Units]; In Commercial Distribution
GS1	20328785000065 [Package]; Package: CASE [24 Units]; In Commercial Distribution
GS1	40328785000069 [Package]; Package: CASE [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043110

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-09

On-Brand Devices [Vicks]

• 00328785990195: Vicks VapoPads, Family Pack (Menthol)
• 70328785707501: HUMIDIFIER, WARM MIST, VICKS
• 70328785705200: VICKS COOL MIST HUMIDIFIER, WHITE, JUVI VERSION
• 10328785502005: VICKS STEAM INHALER
• 70328785405209: VICKS COOL MIST HUMIDIFIER, WHITE
• 20328785401008: STEAM INHALER, VICKS, VELVET PACKAGING
• 00328785347005: HUMIDIFIER, COOL MOISTURE, STARRY NIGHT, VICKS, GREEN, VELVET PACKAGING
• 00328785337006: HUMIDIFIER, COOL MOISTURE, STARRY NIGHT, VICKS, PURPLE, VELVET PACKAGING
• 70328785307503: HUMIDIFIER, WARM MIST, JUVENILE, VICKS
• 00328785251005: HUMIDIFIER, ULTRASONIC, W/SCENT PAD HEATER, VICKS, VELVET PACKAGING
• 20328785218002: VAPORIZER, WATERLESS, VICKS, VELVET PACKAGING
• 50328785217501: VICKS WATERLESS PLUGIN PEG
• 00328785207903: HUMIDIFIER, WARM MIST, GERM FREE, VICKS VELVET PACKAGING
• 70328785207452: HUMIDIFIER, WARMMIST, VICKS, VELVET PACKAGING
• 10328785204251: HUMIDIFIER, IMPELLER, VICKS BABY 1 GALLON, VELVET PACKAGING
• 00328785200195: VSP19 Amason Package
• 20328785200052: VICKS VAPOPAD FAMILY PACK, BABY SCENT
• 20328785190001: VAPORIZER, WATERLESS, VICKS, VELVET PACKAGING
• 70328785146003: VICKS HUMIDIFIER, ULTRASONIC, FILTER-FREE JUVENILE V4600JUV
• 70328785139005: HUMIDIFIER, COOLMIST, GERM FREE, JUVENILE PACKAGING, VELVET PACKAGING
• 00328785117509: VICKS ADVANCED SOOTHING VAPORS WATERLESS PLUG-IN, VELVET PACKAGE
• 20328785101502: VICKS VAPORIZER 1.5 GL LOCKING
• 20328785101052: VICKS VAPORIZER 1 GL LOCKING
• 00328785100372: Humidifier, Cool Moisture, Vicks Starry Night, Pink
• 20328785100055: VAPOPAD, VICKS, JUVENILE, BABY RUB SCENT, 6 PADS/COLOR BOX
• 70328785046006: VICKS HUMIDIIFER, ULTRASONIC, FILTER-FREE V4600
• 10328785039006: HUMIDIFIER, COOLMIST, GERM FREE, VICKS, 1PC MASTER
• 70328785037004: HUMIDIFIER, COOL MOISTURE, STARRY NIGHT, VICKS
• 70328785005751: VICKS COOL MIST ULTRASONIC SWEET DREAMS
• 70328785005706: VICKS HUMIDIFIER, REMOVABLE TOPFILL ULTRASONIC
• 70328785005201: VICKS COOL MIST HUMIDIFIER, GREEN
• 70328785003207: VICKS EVAPORATIVE COOL MOISTURE HUMIDIFIER
• 10328785001997: TWO SECOND DIGITAL THERMOMETER W/ FEVER INSIGHT, FLEXIBLE TIP, F/C READINGS
• 20328785001901: Vicks Lavender VapoPads 12 ct.
• 20328785001895: Vicks Lavender VapoPads 6 ct
• 00328785001549: TWO SECOND DIGITAL THERMOMETER W/ FEVER INSIGHT, FLEXIBLE TIP, F/C READINGS
• 10328785001515: TWO SECOND DIGITAL THERMOMETER W/ FEVER INSIGHT, FLEXIBLE TIP, F/C READINGS, PEDIATRIC PACKAGING
• 10328785001362: VICKS WARM MIST HUMIDIFIER
• 00328785000481: Thermometer, Baby packaging version of V912USV1, 8 sec, SpeedRead
• 00328785000443: Thermometer, Rectal, Baby
• 00328785000436: Thermometer, Pacifier, Baby
• 00328785000283: Thermometer, Vicks SmartTemp digital, w/Bluetooth
• 10328785000273: Thermometer, 8 sec speed read, w/ Fever Insight, BPA free
• 00328785000269: Thermometer, 15 sec, Digital, Audio Fever Signal
• 00328785000115: COMBO PACK - This Kit contains - 6 each of Vicks Retail Thermometers GTIN/UDI Numbers 003287850
• 00328785000061: Thermometer, ComfortFlex, 8sec digital, w/Fever Insight
• 10328785003212: Vick Cool Mist Humidifier w/ Vaposteam Cup
• 00328785002492: V1200-6-VV1
• 10328785004820: VICKS FILTER FREE COOL MIST HUMIDIFIER
• 10328785002055: VICKS LOW-COST EVAPORATIVE HUMIDIFIER